Recalls

MEDICAL DEVICES RECALL LISTINGS: 2009Hazard Classification Type II Trade Name Manufacturer Recall Posting Date Recall Start Date Recall Number Model or Catalog # Lot or Serial # Reason for Recall A) Innova 2100 IQ Digital Imaging System B) Innova 4100 IQ System Colleague Volumetric Infusion Pump Light Wand Orotracheal Lighted Stylet ReSolve Open Back Halo Ring Process System Manager Magellan Platelet Separator Disposables GE Healthcare 2009-01-05 2008-01-03 39234 Baxter Healthcare Corporation Vital Signs Inc. Ossur HF Roche Diagnostics Ltd. Medtronic Inc. 2009-01-05 2009-01-05 2009-01-05 2009-01-05 2009-01-05 2008-03-13 41402 2008-08-11 43632 2008-11-12 45100 2008-12-12 45358 2008-08-19 45455 Type II Type II Type II Type I Type II Reservoirs Maquet Cardiopulmonary AG 2009-01-05 2008-11-18 45565 Type II Cell-Dyn Sapphire Analyzer Abbott Laboratories Diagnostic Division 2009-01-05 2008-12-12 45612 Type III A) Philips Multidiagnost Eleva - Image Intensifier B) Philips Multidiagnost Eleva - Flat Detector C) Omnidiagnost Eleva A) Origin YZ Zirconia Blocks B) Origin YZ Zirconia Discs Precision Charger 1.0 Philips Medical Systems Nederland B.V. 2009-01-05 2008-11-26 45311 Type II White Peaks Dental Systems Boston Scientific Neuromodulation Corporation 2009-01-05 2009-01-05 2008-11-26 44705 2008-09-26 45208 Type II Type II Dri-Lok Disposable Cannulas Stryker Endoscopy 2009-01-05 2008-12-11 45616 Type II HM Reaction Vessels Siemens Healthcare Diagnostics Inc. 2009-01-05 2008-11-25 45624 Type III Tenderflow Pediatric Arterial Cannula Vertier Surgical Table A) Simview 3000 B) Simview NT Therapy Simulator A) Ergolift B) Ergolift-2 Servo 300/300A A) Roche Hitachi - HDL Cholesterol B) Hitachi HDL-C Plus, 3rd Generation C) Cobas C/Integra HDL-C Gen. 3 D) Cobas C 111 HDL-Cholesterol Plus Terumo Cardiovascular Systems Corp. Stryker Communications Siemens Medical Solutions USA, Inc. Oncology Care Systems BHM Medical Inc. 2009-01-05 2009-01-05 2009-01-05 2008-11-11 44891 2008-12-08 45617 2008-12-11 45619 Type II Type II Type II 2009-01-05 2008-12-08 45626 Type I During acquisition (fluoro &/or record), an image could become frozen on DL (digital leader acquisition system) live monitor screen, leading the user to believe it was a live dynamic image instead. 2M8151K Product fitted with incorrect power cord (220v versus 120v) and not labelled as certified to the Canadian electrical requirement CAN/CSA C22.2 no.601.1. 3910, 3960, INTPKF >10 Numbers, Contact Mfr. There is a possibility that the light bulb protector (clear plastic bulb cover) on the end of the stylet may detach from the stylet. 505400D 8040201 The 5/16-24 class 3B threads in the Open Back Halo Rings were tapped with the wrong size or worn taps and do not pass the "go" thread plug gage. 3009696001 VERSION 2.00.02a to 2.01.05a/b Potential for a result to be released to the host (LIS/laboratory information system) before a post analytical rule (namely car rule) is triggered to block the result. BOS370, COS330, MDK300, MDK305 >10 Numbers, Contact Mfr. Becton Dickinson, a supplier of syringes, notified Medtronic that unit package seal integrity (hence sterility) can be adversely affected when exposed to low atmospheric pressure. Syringes are included in kits. BEQ-VHK 2001 276339, Heparin Lot PH64507 Celsus heparin was used during the coating process, manufactured from material that was found to contain the contaminant over-sulfate chondroitin sulfate (OSCS), which mimics heparin's anticoagulant activity. 8H00-01 Cell-Dyn Sappire Hemoglobin Reagent Syringes Cell-Dyn Sapphire 5.0ml hemoglobin reagent syringes were manufactured with a 2.5ml (08H49-02) Labelled With Packaged Dates Of syringe pull instead of the correct 5.0ml syringe pull. 16 Sept 2008. A) 70832 A) N/A A partial grid-switch failure may occur that may result in a higher x-ray dose than expected. B) 70834 B) N/A C) 708027 C) N/A A) N/A A) >10 Numbers, Contact Mfr. The product does not have a Health Canada device licence as per section 26 of the MDR. B) N/A B) >10 Numbers, Contact Mfr. As a result, a recall was issued. N/A >10 Numbers, Contact Mfr. The recall is issued due to reports of burns while using the device. The burns occurred in the area of charging, typically at the abdominal, upper buttock, and less frequently in the subclavicular area. The cannulas leak water when inserted and continue to leak when removed. There has been 3910-075-500, 3910-075-501, 3910-075- 08 135 AG2 - 08 294 AG2 a change in material without Stryker's approval. The new material has different properties 502, 3910-075-650, 3910-075-651, 3910allowing the cannulas to leak. 075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090502, 3910-090-650, 3910-090-652, 3910090-800, 3910-090-802 RXV1A NC16-182-08, NC16-210-08, NC16-238-08, Siemens Healthcare Diagnostics received customer complaints regarding reaction vessels NC16-189-08, NC16-217-08, NC16-245-08, which are leaking while running HM methods. NC16-196-08, NC16-224-08, NC16-203-08, NC16-231-08 Difficulty retracting the introducer of Tenderflow Pediatric Arterial Cannula. 813570, 813572 0502200 0513069 0507121 0512918 0788-100-001S 080118-43529 The Vertier Table was manufactured with bronze bushings at the tilt shaft instead of the validated teflon coated bushings. The bronze bushings may fail due to fatigue. A) 1957153 A) 4034, 4011 The company has become aware of a potential for serious patient injury due to excessive B) 5496992 B) 6037, 6038 wear that may occur to the drive belts used in the image intensifier and/or x-ray head drive mechanisms. A) N/A A) ERLI 0001 To ERLI 1717 BHM received incident reports describing a failure of the structure of the boom. The B) N/A B) ERLI 0001 To ERLI 1717 weakening of the welded joint due to excessive grinding may have caused the fatigue failure. 6079300, 6079391, 6079433, 6150614, 6424704, 6424712, 6424779 A) 04713257190 B) 04713109190, 04713184190, 04713214190, 04713265190 C) 04399803190 D) 04657560190 A) 360-2D, 480-2D, 720-2D B) RM-9103-S, RM-9103-S0, RM-9103S1 69318 APC-20I 667 >10 Numbers, Contact Mfr. Short inspiratory times when using Servo Ventilator 300 automode in neonatal and pediatric patient ranges. A) 697427-01 Some HDLC3 reagent lots may generate a decrease in control recovery and an invalid B) 695354-01, 697430-01, 696347-01, 697431- calibration due to calibration factor drift. 01, 697411-01, 696342-01, 697408-01 C) 695358-01, 696351-01, 601823-01, 694563-01 D) 694566-01 A) All Lots B) All Lots All Lots APC20i-0006 100413, 100805, 100974, 101114, 101511, 101677, 101714, 101769, 101854, 101989, 101576 The importer was selling research use only devices for clinical purposes. A) 2335129-4 B) 2335129-3 A) S/N 515959BU5, 518373BU6, 534731BU5, 476532BU7, 482422BU3 B) S/N 491354BU7 & 508964BU4 >10 Numbers, Contact Mfr. Maquet Critical Care AB Roche Diagnostics GMBH 2009-01-05 2009-01-05 2008-12-17 45668 2008-12-04 44645 Type II Type III A) Autostainer B) Rabbit Monoclonal Antibody Clone SP3 Conform XT- Gloves Autologous Platelet Concentrate System STA-Neoplastine CI Plus 10 Labvision Corporation - Part Of Thermo Fisher Scientific 2009-01-05 2008-07-16 44328 Type III Ansell Healthcare Products LLC Harvest Technologies Corp. Diagnostica Stago SAS 2009-01-05 2009-01-05 2009-01-05 2008-11-20 45563 2008-10-24 45706 2008-10-23 44571 Type II Type II Type II Unlicensed class II medical devices. Lot APC20i-0006 failed the quarterly dose audit for sterility. A potential lack of homogeneity between product vials attributed to a defective excipient in the affected lots of products. This can impact the clotting time performance with the outcome being longer. Hamilton Star Archive Plate Hamilton Medical AG 2009-01-05 2008-06-01 45089 Type III 04639634001, 235656 2732709, 2742732, 2742744, 2714721, 2810259, 2811269 HL14301 The barcode label on the Star Archive Plates used with the Cobas S201 system may not be readable by either the Hamilton Star onboard barcode scanner or a hand held scanner. Complaint received from a customer indicating that the product was received with an incorrect directions for use in the package sleeve (packaged with directions for use for antia1 lectin). Debris could build up inside of the instrument to the point that it is unusable if it becomes heavily soiled. The instrument is designed to remain outside the body and should not become heavily soiled. An increased trend in reports of keypad issues occurring during implementation or shortly after being placed in use. Short circuits in the keypad may make pump inoperable or pump may not respond to keystrokes. The QP2508 hand pendant has experienced a run on condition. The linear actuator motor continues to run until end of its stroke after releasing the push button on hand pendant and then stops. Biophen Heparin 6 lots contain a substrate reagent (R1) that is harder to dissolve than usually. Sorin Group Italia received reports of restricted or blocked flow at the outlet of the minibypass bag adopted into perfusion tubing sets designed for mini-bypass systems for the models and lots specified. Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. It was determined that the difficulty is related to specific manufactured lots. Discovered a short in the foot switch connector. It is possible that delivery of RF energy can begin without depressing the foot switch. Some lots of 12mm thick and 14mm thick provisional devices may have become commingled during manufacturing. Some units which are 12mm thick may be etched and packaged as 14mm thick provisionals and vice versa. Some of the packaging trays were cracked. This may compromise the sterility barrier. If used, the potential affect to the patient may be infection. The sheath's radiographic tip marker band may become dislodged or detached from the sheath during an interventional procedure posing an embolic risk to the patient. Anti-H Lectin Dominion Biologicals Ltd. 2009-01-05 2008-09-30 45736 Type III 0141-0015 Intertan Entry Portal Handle Smith & Nephew, Inc. 2009-01-19 2008-12-15 45713 Type II 7167-4092 > 10 Numbers, Contact Mfr. Medfusion Syringe Pump Smith's Medical MD Inc. 2009-01-19 2008-12-29 45802 Type II 3500-306, 3500-415 >100 Numbers, Contact Mfr. QP2508 Hand Pendant M.C. Healthcare Products Inc. 2009-01-19 2008-12-05 45786 Type II HB43-U010-00/01 N/A Biophen Heparin 6 ref 221006 ECC.O Integrated Mini-Bypass System Hyphen Biomed Sorin Group Italia S.R.L. 2009-01-19 2009-01-19 2008-11-25 45340 2008-12-31 45809 Type III Type II 221006 084221, 085339 80401, 81701, 83306 > 10 Numbers, Contact Mfr. Trupath Biopsy Device Boston Scientific Corporation 2009-01-19 2008-10-22 44611 Type III N/A > 50 Numbers, Contact Mfr. Maestro 3000 Cardiac Ablation Foot SWT Nexgen Complete Knee Solution, Articula Boston Scientific Corporation Zimmer Inc. 2009-01-19 2009-01-19 2008-11-26 45615 2008-12-19 45916 Type II Type II M004218400 00-5971-050-12, 00-5971-050-14 > 100 Numbers, Contact Mfr. 60969810, 60969811, 61007188, 60987590, 60969807, 60976981, 60976982 M00560070, M00560071, M00560100, M00560101, M00560220 > 50 Numbers, Contact Mfr. Gold Probe Electrohemostatic Catheter Soft Tip Introducing Sheath Boston Scientific Corporation Boston Scientific Microvasive 2009-01-19 2009-01-19 2008-12-31 45864 2008-12-31 45865 Type II Type II 6007, 6010, 6012 5660, 5661, 5661ST, 5662, 5662ST, 5663, 5663ST, 5665, 5665ST, 5667ST, 5670, 5670ST, 5671, 5672ST, 5675ST, 5676, 5676ST, 5890ST 7.5.51 SP2, H72 Ximatron Digital Imaging 7.5.51 SP2 Updated recall # 41318 previously posted on 200803-31. Easydiagnost Eleva Varian Medical Systems, Inc. 2009-01-19 2007-06-25 41318 Type I H720702 Philips Medical Systems DMC GMBH 2009-02-02 2009-01-12 45982 Type II 9890 010 03631 N/A Modular Femoral Neck BiPAP Focus Ventilator Power Cord Encore Medical, L.P. Respironics California, Inc. 2009-02-02 2009-02-02 2008-05-27 44847 2008-09-24 45154 Type II Type II N/A 1033869 53872833 Manufactured bef.Mar.27/ 08 A) Advia Centaur System-HIV Enhanced Assay B) Advia Centaur XP System-HIV Enhanced Assay Siemens Healthcare Diagnostics Inc. 2009-02-02 2009-01-08 45980 Type III A) 01463908 B) 01463908 Staphaurex Plus 150/450 BD Integra 1mlTB Syringe Ransel Kit Remel Europe Ltd. Becton Dickinson And Company Randox Laboratories Ltd. 2009-02-02 2009-02-02 2009-02-02 2008-12-03 45985 2008-12-01 45355 2008-12-22 45734 Type II Type III Type III RE30950102, RE30950201 305298 HG1539, RS504, RS505 Simulfluor Flu A/B Immunofluor Assay Millipore Corporation Bioscience Division 2009-02-02 2008-11-21 45681 Type II 3121, 5250 Gendex GXCB-500 Cone Beam 3-D Imaging Imaging Sciences International, Inc. 2009-02-02 2009-01-08 45997 Type II G1-15-1-0 Urovysion Bladder DNA Probe Kit Terumo Advanced Perfusion System 1 Bioplex 2200 Detector Calibration Packs Abbott Molecular Inc. Terumo Cardiovascular Systems Corp. Bio-Rad Laboratories Diagnostics Group 2009-02-02 2009-02-02 2009-02-02 2009-01-04 45862 2009-01-23 46050 2008-12-01 45218 Type III Type II Type II 36-161070 801763 660-0000 Potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as staphylococcus aureus. 8078251 There was a typo error on the label of the 100 unit shelf carton. The expiry date on this label reads 2013-13 when it should read 2013-03 (designating March 2013). 138702, 122999, 100558, 084225, 098485, Instructions for preparation of the HG 1539 reagent, required if using human blood samples 083256, 101130 for application to Ransel Kit, RS 504/ RS 505, are incorrect. The current dilution of 1 + 24 is incorrect, it should be 1 + 4. >10 numbers, Contact Mfr. Millipore confirmed that specific lots of SimulFluor Flu A/B reagent may cross react with respiratory syncytial virus, potentially leading to a misdiagnosis of influenza B, thus a recall was issued. NU010286 The phantom used for calibration of the Gendex GXCB-500 Cone Beam 3-D imaging machine is incorrect and can result in providing inaccurate measurements within the software program. N/A The device is registered as a class II, however it has been shipped with an intended use claim that was not approved and which causes the device to be considered a class III. 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601 The screws in the power MGR board may come loose and come into contact with system 1 chassis, causing a short circuit between the board and the chassis. 950413 Detector calibration packs from lot number 950413 may calibrate the Bioplex 2200 detector module incorrectly leading to the possibility of low count errors for patient samples, assay calibrators, QC material. A) 16384031, 19633033, 28655040, 27767040, 19004033, 30279040, 28082040, 27281040 B) 19633033, 28655040, 16384031, 19004033, 30279040, 28082040, 20234033 J311610, J311510 A software code malfunction has been identified in Ximavision / Ximatron digital imaging v7.5.51.6 sp2. This only affects systems using the Ximatron simulator. Other simulators (eg. Acuity) are not affected. Patient images can be mixed up during viewing and printing. Images of one patient might be stored in the folder of another patient. This can be full images but also part images of two patients on one image. During routine in-house testing a visual discrepancy was found. The visual nonconformance consisted of a scallop feature with twice as many lobes, 24 instead of 12. This corrective action is being taken to address power supply failures on some ventilators. The failures are a result of transient power surges created from disconnection or intermittent electrical connection. Investigation showed some reagent lots exhibited a loss in type O sensitivity which could potentially result in a missed detection of a HIV type O infection specifically during seroconversion. A) Liquicheck Cardiac Markers Control LT - Trilevel B) Liquicheck Cardiac Markers Control LT - Level 1 C) Liquicheck Cardiac Markers Control LT - Level 2 D) Liquicheck Cardiac Markers Control LT - Level 3 E) Liquicheck Cardiac Markers Control LT - Trilevel Minipak Carina Home Ventilator Minute Lab PSA Semi-Quantitative Test A) Achieva 3.0T MRI System-Main Unit B) Achieva 1.5T MRI System-Main Unit C) Achieva XR MRI System-Main Unit D) Intera 1.5T MRI System E) Intera 3.0T MRI System-Main Unit A) Voluson E8 Ultrasound System B) Voluson E8 Expert Ultrasound System Giraffe Omnibed Rear Case Assembly For Auto Syringe Bio-Rad Laboratories 2009-02-02 2008-11-28 45219 Type II A) 145 B) 146 C) 147 D) 148 E) 145X 5703700 PSD-A1, PSS-A1 A) Achieva 3.0T B) Achieva 1.5T C) Achieva XR D) Intera 1.5T E) Intera 3.0T A) N/A B) N/A A) 23430, 23440 B) 23431, 23441 C) 23432, 23442 D) 23433, 23443 E) 23430, 23440 Version 1.1-2.4 PSA 6090007, PSA 6090008 A) N/A B) N/A C) N/A D) N/A E) N/A A) >10 numbers, Contact Mfr. B) D03347, D03345, D03655 NT-proBNP and Troponine I do not meet the 20 day open vial claim. Package insert have been revised to indicate that NT-proBNP will be stable for 10 days and Troponine I will be stable for 8 days at 2-8 c. Draeger Medical B.V. Tremblay Harrison Inc. Philips Medical Systems Nederland B.V. 2009-02-02 2009-02-02 2009-02-02 2009-01-14 46109 2008-09-19 46147 2008-09-26 44066 Type II Type II Type II No device alarm when pilot line gets disconnected. Current product is unable to meet performance requirements which may yield false negative prostate specific antigen results at or near the limit of detection. Lithium polymer battery for the VCG sensor may fail after being physically dropped from a height (i.e.1 metre). The failed battery may produce a flame or emit smoke. The failure may occur instantly or delayed. GE Medical Systems Kretztechnik GMBH & CO OHG 2009-02-02 2008-04-01 42409 Type III Ohmeda Medical, A Division Of Datex Ohmeda Inc. Baxter Healthcare Corporation 2009-02-02 2009-02-02 2008-07-31 43008 2008-09-19 43803 Type II Type II Durepair Dura Regeneration Matrix Medtronic Inc. 2009-02-02 2008-11-17 45672 Type II Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-02-02 2008-11-21 45821 Type II Prosolv Cardiovascular Image and Information Management A) Innova 2100/2100 IQ Digital Monitoring B) Innova 4100 IQ Problem Solving Concepts, Inc. GE Healthcare 2009-02-02 2009-02-16 2008-10-24 46106 2008-06-18 42702 Type II Type II A) Evita 4 B) Evita 2 Dura C) Evita XL A) Securefit Hip Stem - 132 degree B) Securefit Hip Stem - 127 degree C) Solar Shoulder - Humeral Component D) Osteonics Omnifit Hip Stem Access Immunoassay Systems Inhibin A Innova 2121 IQ Vibe Machine Draeger Medical AG & CO. KG 2009-02-16 2008-06-23 42978 Type II Howmedica Osteonics Corporation 2009-02-16 2008-09-22 44184 Type II When focal zoom is activated and M-mode is on, performance measurements on M-mode trace may not be accurate. When sonographer unfreezes the image and freezes again, measurements may or may not be accurate. Omnibed >10 numbers, Contact Mfr. There is an accumulation of debris and discolouration on component assemblies of the device, emphasizing the canopy seal area. 1M8560R AAS5001530RP, AAS5001531RP The ESD grounding squares were incorrectly placed on an AS50 rear case assembly. The conductive copper side instead of the kapton side was incorrectly facing the I/O printed circuit board assembly. 61100, 61103, 61105, 61106, 61107, All Lots Preliminary data suggests that the foreign body reaction of concomitant use of some 61110, 61111, 61113, 61151, 61152, ancillary products with Durepair is more pronounced than Durepair alone and may increase 62105, 62110 rates of other known risks. N/A M00265 With the implementation of version 1.1.2.28, Immucor discovered when a clot was detected, the probe moved to the rinse station before the operator responded to the user prompt whether the probe was clean. PROSOLV CARDIOVASCULAR CL , VERSIONS 3.5.1776, 3.5.1530, 4.0.1.142, A software defect was detected with its cardiology pacs software when exporting a patient's PROSOLV CARDIOVASCULAR SE 3.5.43, 3.0.48 diagnostic images to a CD. A) S18751AM, S18751AP A) S/N's 1203100025, 452849BU3, 112436VE1, The LCD monitor support may disengage from its arm and fall on the table. Incorrect cable B) S18391MD 452927BU7, 524113BU8 routing may cause the ECG monitor power cable to be damaged, potential for short circuit, B) S/N's 1203/00034, 1203/00030, 604/20097, sparks & electric shock. 460566BU3, 112438VE7, 469393BU3 A) 8306611, 8412980 A) ARXM-0005 The power failure alarm generator sporadically emits signal at a high, barely perceptible, B) 8306611, 8411800 B) ARYB-0067 frequency. Affects only units in which the replacement CO2 carrier PCB installed between C) 8306611, 84119600-XX C) ARYB-0044X 2005 and 2008 during a repair. A) 6051-0830S, 6051-0935S, 6051-1140S A) 901MME, EN1MME, J41MLE, 4PMMME Voids of various size were found in the seal area of a series of blisters processed on a B) 6054-0812S, 6054-1014S B) AKKMME, 72MMME specific heat sealer. They are related to a progressive scratch on the heat plate that caused C) 5351-4108 C) VV4MKE the voids in some packaging. D) 6070-0730A, 6070-0830A D) VK0MME, D9VMME, RHWMME A36097 S18821AM N/A N/A S/N 554413BU5 N/A The Inhibin A certificate of analysis has the incorrect unit of measure listed as iu/ml. The correct unit of measure is pg/ml. 1) Intermittent failure associated with the function used to store images. 2) Software failure on the function used to send images for storage on the hard disk. Company did not obtain marketing approval before offering vibe machine for sale...product is a device because it is intended for use in diagnosis of disease or in cure, treatment, or prevention of disease. In certain circumstances, a patient number could be erased and replaced with the patient's hospitalization number. This defect could lead to a patient identification mismatch. Specified lots of sprayed HA stems produced did not meet Stryker's internal material specification for tensile bond strength and crystallinity. Beckman Coulter Inc. GE Healthcare Vibe Technologies 2009-02-16 2009-02-16 2009-02-16 2008-10-15 44413 2008-11-18 45109 2008-12-26 45192 Type III Type III Type III TD-Synergy Software (TD-SYN-01) Technidata S.A.S. 2009-02-16 2008-12-11 45827 Type II N/A N/A A) Osteonics Omnifit M-HA Hip Stem B) Accolade TMZF Press Fit Stem 132 Degree C) Accolade TMZF Press Fit Stem 127 Degree Howmedica Osteonics - Stryker Ireland 2009-02-16 2009-01-06 45981 Type II A) > 10 Numbers, Contact Mfr. A) 6041-0730, 6041-0830, 6041-0935, B) > 10 Numbers, Contact Mfr. 6041-1035, 6041-1140 C) > 10 Numbers, Contact Mfr. B) 6020-0130, 6020-0230, 6020-0335, 6020-0435, 6020-0537, 6020-0637, 60202530, 6020-3535, 6020-4535, 6020-5537 C) 6021-0130, 6021-0230, 6021-0335, 6021-0435, 6021-0537, 6021-2530, 60213535, 6021-4535, 6021-5537 A) GTI-72C, GTI-72L, GTI-72OR B) GTI-B27 C) GTI-DR A) 32.5, 32.6, 32.7, 10.3, 10.7 B) 16.2 C) 55.0 A) HLA Typing Trays B) HLA Typing Trays - B-27 C) HLA Typing Trays - Class II GTI, Inc. 2009-02-16 2009-01-12 46071 Type III Reactivity of HLA Typing Trays has changed since the products were released. At the time of release, product met the specifications for reactivity, but upon storage and shipment, reactivity has declined. 842836. 834298. 843528. Inc. SBA30MNXXX. 838978. 53081. 00223W. 20151. 55203. 53088. 793268. 00210W. 00213W. K) 746846. 55142. Metal objects could fall on the board during servicing of the systems that may result in sparks. 791871. 20163. 20018. 55402. 858988 B) > 10 Numbers. 57052. 10376 I) 40033 J) 35051. 817677.V. O) > 10 Numbers. 00221W. 14041. 855432 T) 753435. 28072 O) 32070 A) S/N'S 280105WK8. 35749. 00216W. Cardinal Health 2009-02-16 2009-02-16 2008-09-24 44279 2008-09-22 44332 Type II Type II A) 53069. Contact Mfr. Contact Mfr. 55168. 44217. 776580. 35216. out & net fluid totals values will not honour the numeric precision configuration. Draeger Medical B. 00224W. Contact Mfr. 53101 B) 55127. SCV30EAXXX S) SCV30AF'XXX' T) SBA30MAXXX Biomet Orthopedics. H) 10037. P) > 10 Numbers. Contact Mfr. Inc. 55303. 46-270157G-1 B) 2275938-7 350805 A) SCV30CBXXX B) SLC30LCXXX C) SCV30AAXXX D) SCV30STXXX. C) > 10 Numbers. SBA30LBXXX. 00218W. 852840 L) > 10 Numbers. Strl. losing decimal point accuracy for low weight patients such as infants. 311216WK6. 853786. 2009-02-16 2008-09-25 44335 Type II A) S2024DT B) S2024EH 00200W. 35531 K) 25006. 35417. 14054. M) 857254 N) > 10 Numbers. 263322WK0. I) 757212. 00225W A) 04385983. 847088. 764645. Outer box labelled as a 2. Contact Mfr. Leaflet fractures. 00201W. 55197. 129501 2M86955 Bard Access Systems. A) OEC Mobile Elite C-Arms Gen.0mm Stainless Steel Crimp Sleeve A) Sterile ECLS Pack B) Sterile Lap Chole Pack C) Sterile Lap Chole Pack D) Ens. 844676. SCV30FPXXX H) SBA30THXXX I) SBA30THXXX J) SOT30RPXXX K) SBA30NPXXX L) SNE30CNXXX. 00215W. 25147 L) 20002. 826942. 28069. 55236. Contact Mfr. SCV30THXXX E) SBA30MLXXX F) SBA30ENXXX G) SCV30FPXXA. 44212. Contact Mfr. 851615 F) > 10 Numbers. 835300. SCV30AOXXX Q) SCV30ABXXX. 841029. 57030. 35177. Ventilating in bipap mode with the pressure rise time set to the highest setting and the expiration time being exactly 0. 758604. 25055. The in. Platform B) OEC Mobile Elite C-Arms Cooling Wizard Low Profile Gastrostomy Device GE OEC Medical Systems Inc. 831416. 00206W. 765517. SLC30LAXXX. Pour Endocholecystectomie G) Ens. 55144. 55209. 55140. 847389. 44102. 827471. Contact Mfr. 2009-02-16 2009-02-16 2008-10-14 44404 2008-10-22 44596 Type III Type II A) 138 B) 138 SRYB-0074. 7728392 H) 59 04 433 I) 7727717 J) 7412807 K) 5904441 L) 5904466 M) 5904649 N) 5904656 O) 7007755 A) AMX 4 Mobile X-ray System B) AMX-4+ Mobile X-ray System 2. 855864 E) 819184. 824596. SLC30LCXXX.0mm crimp sleeve may contain an alternate label on the inner packaging. 20069. 805480. 845580.5 seconds which will lead to inspiration phase stopping and ventilation will resume in 5 seconds. 809371. 787942 A) S/N E9-0148 B) S/N 7019-CMH > 100 Numbers. which could cause leakage from the device of gastric contents and feeding solutions. 25076. 467148WK3 B) S/N 966367WK5 S/N 568400 A) 813434. 00217W. 57123. 219252WK4. A) Advia Centaur XP B) Advia Centaur Oxylog 3000 Ventilator Siemens Healthcare Diagnostics Inc. Pontage Femora-Poplite H) Sterile Emergency Chest Pack I) Sterile Aneurysm Pack J) Strl. 773368. 20215 M) 14026. 57068. 2006. 153163. 834460. Q) > 10 Numbers. 55080. 28064. 846104. Contact Mfr. 814976. 10311. 44274. 57119. Customs kits manufactured by Source Medical contain titanium clips being recalled by Teleflex Medical. SCV30CVXXX. 00203W. which will display a whole number. 839638. 35195. 824689. 28048. 57064. G) > 10 Numbers. 55119. SBA30OL'XXX'. 57026. . H) > 10 Numbers. SNE30CRXXX M) SBA30MYXXX N) SBA30ELXXX. 844698. 848983. 820299. 826324. Ambulatory Minor Vacular Pack P) Sterile AAA Victoria Pack Q) Ens. S) 757636. 00204W. 129501 B) 04385983. 55437. Contact Mfr. Pour Sternotomie E) Sterile Major Laparoscopic Pack F) Ens. 2009-02-16 2008-10-09 44381 Type II The device may not conform to Federal regulations for proper beam alignment and overlap requirements in the mag 1 or mag 2 X-ray mode for systems manufactured on or after June 10. Contact Mfr. 784768. 55145. 788682. Strl Chirurgie De L'Aorte S) Sterile AV Fistula Pack T) Sterile Major Abdominal Pack GE Healthcare 2009-02-16 2008-10-03 44190 Type II A) 2115090. 00222W. 35219. SRYB-0132 Diamond Mammography X-ray Equipment GE Healthcare 2009-02-16 2008-10-09 44731 Type II 81000 S/N'S 20572 & 20693 Centricity QS Perinatal System GE Healthcare Integrated IT Solutions 2009-02-16 2008-10-02 45092 Type II 2033579-008 S/N'S J4RR1420F. 55257. A customer safety advisory notice was issued to notify customers about important instructions regarding patient safety on the Artis system. Contact Mfr. 00205W. 35391. 00207W. L4RR1515F A low bias between serum and the plasma samples is greater on reagent lot 138 when compared to other lots. 57160 D) 49003 E) 157105 F) 146106 G) 153146. 852782 J) > 10 Numbers.A) Axiom Artis DBA B) Axiom Artis DTA C) Axiom Artis DMP D) Axiom Artis DBC E) Artis Zee Multi-Purpose F) Artis Zee Ceiling G) Artis Zee Biplane H) Axiom Artis FC I) Axiom Artis DFC J) Axiom Artis DFC K) Axiom Artis FA L) Axiom Artis MP M) Axiom Artis BC N) Axiom Artis BA O) Axiom Artis TA Siemens AG 2009-02-16 2008-08-06 43374 Type II A) 7555357 B) 7008605 C) 7555365 D) 59 17 054 E) 10094139 F) 10094137 G) 10094141. SCV30ACXXX R) SCV30CEXXX. D) 826939. 00202W. Radical Prostatectomy Pack K) Sterile Nephrectomy Pack L) Sterile Craniotomy Pack M) Sterile Mastectomy Vic Pack N) Oto-Rhino-Laringologie Mineure O) Strl. 55122 C) 57017. 53097. 851508. Screws holding the rails on the easy compression system (ECS) assembly were not appropriately tightened and could create a potential hazardous situation if the C-arms were to fall. 55433. 57047. 797005. Contact Mfr. Pontageaorto Bifemoral R) Ens. SLC30LPXXX O) SBA30MVRHA P) SBA30AAXXX. 00212W. 20070. 00214W. 20039. 829163. 55143. Battery sensor board was not insulated. 28022. 796554. R) > 10 Numbers. 14080 N) 28016. 35298. 55092. 000631 A) 0066238 B) 0006428 N/A A59102.4): the software incorrectly reloads a save state/save tracking & display incorrect vessel name over restored images. When using PROPELLER T2 FLAIR application on 3T HD systems the surface coil intensity correction image enhancement option made Hippocampus brighter than images taken with the SCIC option off. B78001ME. 5174073. If the retaining ring inside the column assembly is not inspected and replaced when worn or loose there is the potential for the supporting cable to become detached from the column causing the column to fall.Main Unit B) 1. Contact Mfr. The transducer used for pulmonary gating kit of the CT subsystem relays inaccurate signals in the bellows system. Invivo Corporation 2009-02-16 2009-02-16 2008-11-17 46242 2008-08-13 46281 Type II Type II 4-312B 9065 S07C06 Date Codes 2808 And Lower Signa 3. 97525 Patient On-Line A) 3. M001434511. Steerocath Steerable Catheter Non Temperature Boston Scientific Microvasive 2009-02-16 2008-02-20 46322 Type III 2028BL 0011043537. 0011069509. When the zoom mode is used for breast imaging. M001434571. Immucor Inc. 07E025.0. Mismatch of vessel labels. and an e-stop condition. The failure may occur instantly or after short period. 7455. B77001ST. B79831SR. Difficulty cocking or arming the cannula latch on the device. Specifically. There is a software code error. Failed battery may momentarily produce a flame and then emit smoke. 5142883. resulting in a noncompliance with regulatory requirements. Duralite Pyramid Receiver Proximal Adaptor A) Easy Core Biopsy System B) Easy Core Biopsy Needle . 8731. 11532167.5T Signa HDX MR System . Medtronic Minimed 2009-02-16 2009-01-12 46194 Type III Ceiling Tube Mount With Column Extensions DEL Medical Imaging Corporation 2009-02-16 2009-01-26 46273 Type II CTM/DCTM Contact Mfr. When scrolling through the images of a series. 11520676. 10686. Dome develops a tear during device stretch & distention with an obturator or the obturator may slip out of the pocket during placement. 69491G. Inc. All vials within the product lot have been printed with the same serial number. 62427G. Siemens Medical Solutions USA.Main Unit A) Uroview 2800 System . Fuji Film Medical Systems USA. B) 62426G. The back pressure and inflow check valves may leak. 11520769 B) 11524375. 12198. The cassette interface board fails to establish communications with other devices and losing the electronic agent level indicator with no alarms given. which could result in inaccurate calculations and displays of the group peritonitis rate. 11547760. AW Volumeshare (4. Contact Mfr. P51801BP 1500181 1011-8302-000 A) N/A B) N/A C) N/A A) > 10 Numbers. 59993G. M001434521. Ground path on the workstation mounting bracket is suspect. The lithium polymer battery may fail after being physically dropped from a height. There is potential to have incorrect patient information associated with results on the DxI console and DxI printed reports when the DxC database is renewed. Boston Scientific identified. P6-0528-R. 11550539. A) P6-0404-R. Contact Mfr. Inc. Low Profile U-Joint Driver with instances of the tips remaining in the patients. Inc.# 2850101 A) S/N#S 251168MR1. P4-0433-R. P6-0390R.Delta Notch The Ohio Willow Wood Company Boston Scientific Corporation 2009-02-16 2009-02-16 2008-09-11 44165 2008-10-24 44614 Type II Type III FND-136102 A) M001434561. 8733. Burns occurred in the area of charging while using the charger 1. Contact Mfr. 11625. HURE3333. 0011059410. 0206 7392. M001434601 B) M001434501. HURJ1533. A59126 SC-5300 A) N211037. Inc. 0011049772. M001434531. M001434541 Synfix LR. Reports of charger 1.A) Gemini GXL 6/10/16 Slice PET/CT System B) Gemini TF 16 PET/CT System C) Gemini TF 64 PET/CT System A) Advantage Workstation Version 4. This could result in an image being displayed with an incorrect phase of the respiratory cycle. 7831GQ1. 11535832. 11642796. 11520532. AW version 4. There is an error in Solutions Software for iPRO (model MMT-7319 version 2. Miltex Stainless Steel Surgical Blades 3160 MRI Sytem-Power Battery Components Miltex. 10949.0 burns have been reported. B79991EP. the scrolling appears choppy.1A) when the program is set to display blood glucose values in mmol/litre and they are exported for use in another program. 11516922. 63624G C) > 10 Numbers. hesitates. 8015. Inc. M001434581. 07F012. Inc. 0011078605 Software Version 4. through internal testing of the product a potential of a breach to the sterile barrier. 8768.2. P4-0376-R. The blades appear to have an excessive taper at the tip of the blade and may break during use. a burning smell. 11569929. 2009-02-16 2009-02-16 2009-02-16 2009-02-16 2009-02-16 2009-02-16 2008-05-16 42263 2008-12-15 45761 2008-12-18 46160 2009-01-21 46185 2008-09-26 44523 2008-10-14 46012 Type II Type III Type III Type II Type II Type II 000630. 2009-02-16 2008-07-28 43310 Type II The pin and clip may fracture during surgery. HURG1431. 2009-02-16 2009-01-16 46137 Type II GE Healthcare 2009-02-16 2008-04-04 42738 Type II Floseal Endoscopic Applicator Aisys Anesthesia Carestation Baxter Healthcare Corporation Datex-Ohmeda. . N211039 B) N211038. Oncology Care Systems 2009-02-16 2009-02-16 2009-01-19 46154 2009-01-22 46187 Type II Type II 03. Low Profile U-Joint Driver Artiste MV Synthes (Canada) Ltd. HURJ0568 A) 228083 B) 221299 N/A 0205. 11539484. 11724 A) N/A B) N/A N/A Complaints received for distal tip breakage of the Synfix LR. M3335JG A) 00-870638-02 B) 00-870637-02 C) 2350023 D) 00-870632-05. M001434591. there is a spatial distortion that can be seen on 3D lateral images. 08A027 > 10 Numbers. P4-0400-R B) > 10 Numbers. Boston Scientific Neuromodulation Corporation Philips Medical Systems (Cleveland). Inc. 11546134. This will disable the system rotate motion and all other motions. Beckman Coulter Inc. 5183998.Urological Table B) OEC Miniview 6800 Digital Mobile Unit C) OEC Flexview 8800 Standard C-Arm D) OEC 9800 Plus Mobile Digital System Modular Microplasty Cup Inserter Fresenius AG GE Healthcare GE OEC Medical Systems Inc. Inc. 1078GQ5 B) > 10 Numbers. 5173500. Contact Mfr. B77121VB.2 B) AW Volumeshare C) AW Volumeshare 2 Philips Medical Systems (Cleveland).3) & AW Volumeshare 2(4. Single fault conditions exist that could energize the mounting bracket. Investigation shows that is related to specific manufactured lots.Magnet GE Healthcare 2009-02-16 2008-04-04 41528 Type II N/A N/A Ponsky Non-Balloon Gastrostomy Tube A) Capture-CMV Indicator Red Cells B) Capture-S Indicator Red Cells Fuji Synapse Image & Information System Unicel DXC 880I Synchron Access Clinical System Precision Spinal Cord Stimulation System A) Axis Variable-Angle Dual-Detector Gamma B) Irix Triple Detector Camera CGMS IPRO System .231 8139789 N/A A) 11524979.802. 2009-02-16 2009-02-16 2009-02-16 2008-04-06 41821 2008-05-23 42811 2008-04-25 42976 Type II Type II Type II N/A A) M3335JM B) M3335JB. 11554902.0T Signa HDX MR System .201 Cat. This difficulty may result in an inability to use the device. Affected lots were found to be non-conforming to firm's explicit specifications. 11551300 N/A S/N 5414 There was a presence of a dark discolouration of the Floseal material as it was pushed through the sleeve. 2274023 N/A Biomet. B79991SS B) B79991SS C) 2378698-2. the IL26 accessory insertion interlock indication may disappear from the monitor even if the accessory is not locked in accessory holder preventing gantry and collimator motion. 11535831.0T Excite HD . On inserting the accessory. Contact Mfr. N211040 MMT-7319 HURJ0589. jumps ahead and is not smooth.Solutions Software Bard Access Systems. 11579252. 11516921. 14513A. C) N/A D) > 10 Numbers. the package seal may degrade after sterilization. Devices may overheat (that have the active shunt module retrofit) resulting in the appearance of smoke. 11460. In-house long term testing has indicated the adapter may crack in extreme situations. 11532173. 11634771. 2009-02-16 2009-02-16 2008-08-06 43320 2008-10-15 43371 Type II Type III A) 4535 673 04201 B) 4535 673 89331 C) 4550 110 09021 A) 2378698-2. H25801BP. 11518343. P6-0396-L. 2009-02-16 2008-11-08 45053 Type III 01-1100 Vitros DT Calibrator Kit 2009-03-02 2009-02-03 46501 Type III 1957927 25 And Above Logiciel TDHisto/Cyto Software A) Engstrom Carestation B) Engstrom Carestation .Humeral B) Coonrad-Morrey Total Elbow . MRT 5111. > 10 Numbers. There was a cross mix between two batches of Triathlon Primary Cemented Baseplates. An issue has been identified that in desktop pro release 6.Patient Monitor B) Patient Data Module Datex-Ohmeda Network Aand Icentral GE Healthcare 2009-02-16 2008-08-26 43880 Type II > 100 Numbers. Patient jacket content may mis-match image displayed. 1-2 minutes as a result of unexpected reset of Solar 8000i monitor. K2004Z. The inner label is the correct label. for machine operation in the hemofiltration mode. K2006WF. K2033LB. size 2 and size 4. There is an increase in frequency of drain time errors (3X223. Contact Mfr. 1) Operating manual incorrectly depicts the connection of the filtrate line & filter. 667910.2 and 7. 32-8105-043-02. VT>2 & PVC(1) when used with ApexPro. Correct amount of water should be 225ml. K2022PJ. K2033LG. 667911. 662546 A) N/A B) N/A NEBATO 124001 TO 124515. there is a possible error (of up to 8mm) in the reported table longitudinal position. Hexapod ready 133801 to 133860. Bio-Rad recommends to carefully review the summary report for duplicate tube position numbers or barcode ID within the same rack. 32-8105-027-06 A) N/A B) 32-8105-043-01.6T System Elekta Precise Treatment Table Oxoid Limited Bio-Rad Laboratories Diagnostics Group 2009-02-16 2009-02-16 2008-08-18 45182 2009-02-02 46347 Type II Type I CM0895B A) N/A B) N/A MRT 5071. K2022SA. The surestart function may not operate normally and the exam plan may be interrupted or the scan start timing of the actual scan may be delayed as a result. 2009-02-16 2009-01-22 46193 Type II A) 030002-03 B) 030002-03 C) 030002-03 A) F0813 B) F0813 C) C0181R Bremer Halo Mayfield Adapter Depuy Spine 2009-02-16 2009-01-30 46344 Type III AC003 055561.07-20 TSX-301A/2 > 10 Numbers. Contact Mfr.Ulnar Abbott Prism HBsAg Zimmer Inc. K2022PG. K2022SE. K2033SF. Datex-Ohmeda.A. Axesse NPSS 133801 to 133860 040712.5 software B) Variant II Turbo with CDM 3. Philips Bougie 2009-02-16 2009-01-23 46373 Type II AG55XX All Manufactured Between 2003-2008 Stille Sonestra 6210 Fluoroscopy Table Stille AB 2009-02-16 2008-08-27 44642 Type II N/A N/A Oxoid Fraser Broth Base A) Variant II System with CDM 3. K2030MR. Problem occurred when solar 8000i. K2006WJ. K2006WE. K2006WD. 2009-03-02 2009-03-02 2009-03-02 2009-03-02 2008-12-31 46270 2009-01-22 46271 2009-01-27 46272 2009-02-06 46533 Type II Type III Type II Type II 00-7806-035-01. K2022PF. female metric thread.Trolley Options Aquarius System Technidata S. K2033L. Edwards Lifesciences LLC 2009-03-02 2009-03-02 2009-03-02 2008-10-11 44729 2008-02-12 40775 2008-12-01 45544 Type II Type II Type II N/A A) 1505-9000-000 B) 1505-8538-000 GEF09700 N/A A) > 10 Numbers. It was determined that the instruction provided could be misinterpreted.32. for the specified lots. K2022SF. 060622.0 sites with precise table. K2006WC. K2006WH. Inc. There is a remote circumstance that could cause a capacitor in the vacuum pump component of the system to overheat and potentially create a hazardous condition inside the system. K2070L. The calibrator kit storage and stability conditions require an update for lots 25 and above. 32. There is potential of the C-clip located near the connection end could fracture or fall off the device and into the wound. P0001KA. Minimally Invasive Solutions Technology Offset Rasp Handles CoCr Head 0 32/+4L Taper 12/14 Aquilion One A) Coonrad-Morrey Total Elbow .1.Centricity PACS Workstation Software GE Healthcare Integrated IT Solutions 2009-02-16 2008-11-17 43840 Type II A) Solar 8000I System . 3X225) leading to results not being generated when testing some patient samples with lot number 68761HN00. Inc. GE Healthcare Findland OY 2009-02-16 2008-12-17 44822 Type II A) Immulite 2000 System-Analyzer Class III B) Immulite 2000 System-Analyzer Class II C) Immulite 2000-Instrument Class IV Siemens Healthcare Diagnostics Inc.B) N/A 8105-093-01. K2022SC. 00-7806-035-02 14. patient data module and telemetry used in combo mode. Product labelled as 9-10mm Ezloc Femoral Fixation "standard length" actually contained "long length". CHINA 125001 TO 126001. Contact Mfr. Contact Mfr. Abbott GMBH & Co. M1113715 > 10 Numbers. dash or eagle (cardiac package software only). Zimmer GMBH Toshiba Medical Systems Corporation Zimmer Inc.S. user may think old study is new one. 32-8105-093-02 3A47-48 68761HN00 9-10mm Ezloc Femoral Fixation Device Triathlon Primary Cemented Baseplate Biomet Sports Medicine. K2030JN. 2405362 N/A The outer label of the Unisplint rubber bands (part of Maxillofacial Fracture Kit) indicated natural rubber latex while the inner label indicated latex free. Labelling error. K2033LC. 649794. resulting in smoke and/or fire. 2) Deviations in the total fluid loss (TFL) balance alarm. 3X224. Such duplication could potentially lead to discrepant sample results. The metallic tip detached from the shaft upon or prior to using the device. K2022SB. K2004W. If DDP configured to place current & historical studies in different regions than system default. K2006WB. An investigation revealed that the digital fluidics PC board (PN 450116-002) contains an engineering design flaw (a missing jumper) which affects samples diluted on board. 2)VT>2 & PVC(1) when used with solar. The calibrator response may be lower than expected for alkaline phosphates for concentrations above 400 u/l. Maxillofacial Fracture Kin Walter Lorenz Surgical. 522267 Elekta Limited 2009-02-16 2009-01-23 46393 Type II Loss of monitoring at Solar 8000i for approx. Inc. Review of the current surgical technique was initiated relative to canal preparation for the extra-small humeral component. A short circuit may lead to a malfunction in the control box.G. One vigilance case & 2 complaints were received in 2008 in relation to the Philips catheter. There is a missing thread feature on both components of the device (the anterior and posterior adapters) that would make the unit unusable because it will not attach to the Mayfield swivel adapter. B) > 10 Numbers. K2033LE. K2022PE. Dual fault failure mode of Engstrom system may occur that can cause patient airway pressures to exceed the user settable PMAX limit. Portuguese instructions for preparation indicate to add 12. K2022PH. Some units from this lot may not be etched with the item number and lot number on the rim. Also Trading As: Biomet Microfixation Ortho-Clinical Diagnostics Inc. 055562 Sterrad 50 Sterilizer Advanced Sterilization Products. K2033SE. MRT 5121 649795. K2006WG.9g of CM0895 to one litre of water. K2022SD. Contact Mfr. This can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply. 1 eye. Contact Mfr. K. A user working in TDHC who launches the "work in progress" function is attributed the rights of another user. Howmedica Osteonics Corporation 2009-03-02 2009-03-02 2008-09-18 44280 2009-01-23 46208 Type II Type II 904781 5520-B-400 164080 J5119SH8NT . Contact Mfr. Unisplint. P0001KC A) SLR8KI-XXX-XXX-XXX-XXX A) N/A B) PDM-XXX-XXX-XXXX B) N/A M1113714. 2009-03-02 2009-02-06 46534 Type III A) 32-8105-027-04. A Division Of Ethicon Coloplast A/S 2009-02-16 2009-01-13 46352 Type II 10050 > 10 Numbers. / Une enquête a révélé que la carte de circuits imprimés de logique fluidique (numéro de pièce 450116-002) comporte un défaut de conception technique (cavalier manquant) qui concerne la dilution d’échantillon par la carte électronique. K2033JF. 6. K2022PD. 2023617-XXX. ICentral does not provide audio or visual alarms for: 1) AFIB. 0 kit have been rejected during real time product stability testings: on “high level. Z969H B) DC512. for the specified lots. 175592713.E. A) 872728. VCP602H. A) Brilliance CT Big Bore System .I. due to a failure in the sterilization process. 175597-737. Contact Mfr. Inc.1 & Higher Once individual MLC leaf position edits are made. CA17501263. Computerized Medical Systems 2009-03-02 2009-03-02 2008-12-23 45860 2009-02-06 46521 Type II Type II 5729 N/A Cytomics FC 500 Flow Cytometry System A) Sterile Pacemaker and Defibrillator Pack B) Sterile Shoulder Pack Enzymatic Creatinine Assay Amsorb Plus Prefilled Bubble-Can Universal WTOV Beckman Coulter Inc. 175597-737. Inc. 175518135. J546G. size 2 and size 4. Cracking and leaking of the chamber compromises the sterility of the device raising contamination issues. Fastrac "Pull" Gastric Access Port Kit Focal Software CD Bard Access Systems. During internal testing. DNM 8153 C) 2M9161 D) 2M9163 E) DNM9163 F) DNM9163 101638 A) 03039070 B) 03039070 C) 03039070 D) 03039070 E) 03039070 F) 03039070 G) 03039070 08LM02210 A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers 07DM13310. J699H. Contact Manufacturer 164CCC. 175542364 B) CA12420092. 175573189. a number of devices exhibited signs of damaged packaging. Z320H. Damaged batteries.1. 8120271. APM980 Ethicon is conducting a recall of 21 lots and 19 corresponding product codes of absorbable sutures for which sterility cannot be assured. APM400. APM401. Looped portion of the grasping snare may detach from the crimp and remain in the patient during the guidewire grasping and replacement process. and post-op causing loss of functionality of the product. B) APM272. VCPB340H A) 4535 670 88051 B) 4550 110 02031 03-2794-0 7142-4053 8090272. AP2615 C) APZ490. which may lead to compromised sterility. 175518135. 175535293. Inc. Baxter Healthcare Corporation 2009-03-02 2009-03-02 2009-01-23 46556 2009-01-28 45280 Type II Type II Smith & Nephew. 2 specific sequence of events lead to invalid infusion register state. CA12430055 There is an incorrect radius in the taper of the 36mm -3 heads. 175542364 D) CA12240081. Bio-Rad Laboratories. Some tests of the GS HbsAg EIA 3. AP6072. Inc. 08FM16961 Hinges are cracking/breaking pre-op. CA12220026 E) CA12340052 F) CA12340052 G) CA12420092. 2M8163. 175516117. Cardinal Health Genzyme Diagnostics P.Workplace Hemodialysis Blood Tubing Set Legion Press Fit Stems Philips Medical Systems (Cleveland). 175581661. Oxinium Femoral Heads 36mm -3 GS HBsAg EIA 3. A 46mm head was lasered and packaged as a 45mm head. 2009-03-02 2009-02-02 46404 Type II A) Z117H. 175588693. Z305H D) MCP496G E) VCP416H. Isocenter shift made in XIO will also cause same. APZ363. > 10 Numbers. 2009-03-16 2009-03-16 2009-01-29 46557 2009-02-16 46713 Type II Type III 71343603 32591 > 10 Numbers. J547G. APM982. 175581661. 8070771 During a routine shelf-life aging test. This could result in the tapers not locking fully or properly on the stems.Main Unit B) Brilliance CT Big Bore System . 175535294. 32689. 175588-693. 175528239. J286G. 175528239. 8100771. APM298. which may result in potential blood exposure and/or blood loss for the patient. 08090F12 Upward force of the inner sealing ring on the mating surface of the Drager Clic adapter is insufficient to fully open the gas circuit due to a defect in the plastics body resulting in absorbent failure. J945H C) Z-991G. 175516117. Armstrong Medical Limited 2009-03-02 2009-03-02 2009-03-02 2009-03-02 2009-02-11 46568 2009-02-11 46636 2009-02-12 46641 2009-02-05 46652 Type III Type II Type II Type II 626553 A) SAN30PAXXX B) SOP30ASXXX N/A N/A Blood Tubing Set for Hemodialysis Nipro Corporation 2009-03-02 2008-12-10 45627 Type II A230TR/V810TR A) PDSII (Polydioxanone) Monofilament Suture B) Coated Vicryl Absorable Suture C) PDS II (Polydioxanone) Suture D) Monocryl Plus Antibacterial Suture E) Coated Vicryl Plus Antibacterial Suture Ethicon Inc. APM775. CA12420093. pump may short circuit due to fluid ingress or compromised insulation. faults in internal communications of pump. 32565.0 Smith & Nephew. 8110571. 32120. Fresenius Medical Care North America Smith & Nephew. 176504. Siemens Healthcare Diagnostics Inc. Maquet Cardiovascular LLC Maquet Cardiovascular LLC 2009-03-02 2009-03-02 2009-03-02 2009-03-02 2009-01-29 46302 2009-02-02 46543 2009-02-06 46544 2009-02-09 46546 Type II Type III Type II Type I 5520-B-200 AC-57F1 VH-2000 HSK-2038. APM984. 235CCC . 175535293. APM384. Further edit will snap MLC leaves back to original aperture. 8101072 During a routine shelf-life aging test. 175592713. / L’étiquette extérieure sur l’emballage d’une tige de 20 mm x 160 mm fabriquée par la société Legion indique qu’elle est de 10 mm x 160 mm. N/A Erroneous but credible results may be generated when prism plot results are not updated consistently when exported to spreadsheet software. 2009-03-02 2009-03-16 2009-01-29 46558 2009-02-18 46691 Type II Type III 126646 A) 2M8151. 175535294. low absorbance values were observed when using kits from this batch. Inc. 8102 Cracking of the priming set drip chamber which is pre-attached to the arterial line was reported. CA12430054. Investigation has shown the cause of the low absorbance values to be the biotin buffer. APZ372 A) N/A B) N/A > 10 Numbers.The reagent is not meeting the current on-board stability claims of 20 days without reagent container inserts in the new XL versions of software. Contact Mfr.” the optical density of the kit positive control was less than the lowest acceptable limit. DNM 8151 B) 2M8153.Triathlon Primary Cemented Baseplate Octeia 25-Hydroxy Vitamin D Kit Vasoview 6 Endoscopic Vessel Harvesting Heartstring II Proximal Seal System Howmedica Osteonics Corporation Immunodiagnostic Systems Ltd. which may lead to compromised sterility which has 30% chance of death as the contamination is on the bloodstream. 768. a small number of devices exhibited signs of damaged packaging. 179CCC. CA17501263. 176504-768. 175516116. VCP534H. CA12240082. 175518134. APM844 D) APZ414 E) AP2599. HSK-2043 SJE3F 62729 There was a cross mix between two batches of Triathlon Primary Cemented Baseplates. VCP615H. 2009-03-02 2009-03-02 2009-03-02 2009-02-11 46654 2008-11-27 45519 2009-01-23 46554 Type II Type II Type III Tandem Unipolar 46mm Femoral Heads A) Colleague Volumetric Infusion Pump B) Colleague 3 Volumetric Infusion Pump C) Colleague Guardian Enhanced CXE Pump D) Colleague Guardian Enhanced 3CXE Pump E) French Colleague CXE Volumetric Pump F) French Colleague 3 CXE Volumetric Pump Pip Fixation Hinge Kit A) Advia 1650 Creatinine (CREA) Assay B) Advia 2400 Creatinine 2 (CREA_2) Assay C) Advia 1650 Creatinine (CREA) Assay D) Advia 1200 Creatinine 2 Assay (CREA 2) E) Advia 1800 Creatinine 2 (CREA_2) Assay F) Advia 1800 Creatinine (CREA) Assay G) Advia 2400 Creatinine (CREA) Assay Smith & Nephew. Release 4. APZ116. APZ804. impingement and/or wear debris. 2M8161. A) 175572616. CA17551062. intra-op. J834G. 175516116. APM324. 32383 Five kit lots of product were incorrectly labelled with a date that extends past their 18 month expiration. A Legion 20mm x 160mm stem was packaged as a legion 10mm x 160 mm stem on the outer label. Inc. 31895. CA12420093. Post-op failures have resulted in loss of distraction/reduction. 8090571. On specific lot numbers of twister combiset bloodlines a twister port may crack and separate. 175573189. 875378 The recall has been initiated due to a failure in the sterilization and the manufacturer is B) 872013 unable to assure the sterility of these products. Inc. original MLC aperture is retained. Inc. CA12430054. CA12430055 C) 175572616. CA17551062. A) APM797. 175518134. 06DM08612 There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID. J544G. CA17501263. Interpretation of last result written will be superimposed on with the first result written. CA12330001.002. 11135012. the Dextran Interference Specification. Synthes (Canada) Ltd. 2009-03-16 2009-02-11 46553 Type II A) 005729 B) 005739 The labelling is being corrected on page 16 of the zero P instruments and implants technique guide. CA12310091. CA12430055. 175516116. 11016014. CA176504-768. 2335129-5. Pocket And Cellular Viewers Sybron Endo Arrow International. This is to ensure that surgeons always use the torque limiting attachment with the Stardrive screwdriver. Contact Manufacturer I) > 10 Numbers. T8. Contact Manufacturer Serial Numbers Less Than X09B200000 A) > 10 Numbers. Possibility that choice of patient will be changed when using filtered work lists. This affects PCR Eleva system connected to a RIS.0 ML A) PCR Eleva S Plus B) PCR Eleva Corado Brilliance ICT System-System Abbott Laboratories Diagnostic Division Philips Medical Systems DMC GMBH 2009-03-16 2009-03-16 2009-02-23 46767 2009-02-23 46769 Type III Type II 08H67-01 A) PCR Eleva S Plus B) PCR Eleva Corado 728306 N/A A) N/A B) N/A N/A Philips Medical Systems (Cleveland). CA12320093. Serial Numbers 11259008. 00000000VEN004000. 175528239. Contact Manufacturer A) HUSD0351 B) HUSD0126 & HUSD1972 A) N/A B) N/A CELL-DYN Ruby system (software V 2. hand cut that had to be sutured. Patient's hand squeezed in the gap between the table and the gantry. CA12310054 C) 175542364. Patient can not be ventilated. Defective battery charger caused the loss of the mains power and unit could not be turned back on. CA12220026 B) CA12330010. 175573189. Contact Manufacturer H) > 10 Numbers. 11135012. 2335139-4 B) 2335129. 2009-03-16 2009-02-02 46515 Type II 87000 E. 7-1258 A) > 10 Numbers. Contact Manufacturer C) > 10 Numbers. Contact Manufacturer D) > 10 Numbers. .0. CA12250055. 2009-03-16 2009-03-16 2009-02-24 46779 2009-02-09 46517 Type II Type I N/A A) IAB-04840-U B) IAB-04830-U C) IAB-R950-U D) IAB-S840C E) IAB-S730C F) IAB-05830-U. CA12250088. CA12320089. after cycling power to the analyzer. Inc. CA12440048. were found to be missing the following information: lot number. Normally problem detected because the "active" name of patient is displayed. CA12240082. CA12310069.Cell-Dyn Ruby With System Software V2. Patient suffered a 11200010. IAK-02692 H) IAB-06840-U I) IAB-05830-LWS.40 or 50cc.902 B) 03. Inc. S18741AM N/A A) 000256 B) 000292 A) 03. CA175588-693. date of manufacture. differing only in case (which is possible with Echo software). Inc.CAM PHS FOV Siemens Medical Solutions USA. 3) Mobile care software/mobile viewers and iCentral might generate false positive alarms. Bottle labels from lot 211974M AxSYM System Tubing Decontamination Solution (list 211974 number 7B05-09). CA12240081. 175572616. Contact Manufacturer F) > 10 Numbers. CA12340052. 4381088 AxSym Sustem Tubing Decontamination Solution 2009-03-16 2009-02-24 46832 Type II 7A83-01 Periowave Photo-Disinfection System Ondine Biopharma Corporation 2009-03-16 2008-11-25 46928 Type III N/A A) Advia 1200 Total Protein II (TP) Assay B) Advia 1800 Total Protein II (TP) Assay C) Advia 1650 Total Protein II (TP) Assay D) Advia 2400 Total Protein II (TP) ASSAY Siemens Healthcare Diagnostics Inc. 175597-737 D) CA12430022. Contact Manufacturer G) > 10 Numbers. Blue connector for 40cc IAB not properly recognized by IAB pump system. CA12440035. Pin of feeding adaptors may not be aligned which create a restriction within the adaptor preventing food from getting through the occlusion. CA12320016. CA17551062. CA12320094. Manual B) Torque Limiting Attachment Web. 7-1221. Contact Manufacturer Customer safety advisory notice regarding patient attempts to pull themselves up using the patient handling system field of view flip-up armrests without assistance. Research and development studies determined that freshly opened reagent does not pass A) CA12250055. Molecular Imaging Group Abbott Laboratories Diagnostic Division 2009-03-16 2009-02-03 46563 Type III 4366618. Artifact may appear if combination of 80KV and either a UA. 175535294. Fault in connector of pump tubing assembly may result in volume setting on pump defaulting to 2.110. during brain scans and brain perfusion studies. CA12260038. There is no monitoring to warn the user the battery voltage is low and is about to shut down. Contact Manufacturer E) > 10 Numbers. 2) Mobile care software/mobile viewers do not recognize Apexpro FH telemetry transmitter. 175518135. 11016013. Inc. CA12430054. CA12320015. CA12310055. UB or UC filter is used for reconstruction of the images. Contact Manufacturer B) > 10 Numbers. CA12420093.5. CA12320088. which in turn may cause leakage and need for retreatment. CA12330020. CA12260006. CA12440034. 175518134. a Zoll AED Plus Defibrillator may prompt "change batteries" during use and fail to deliver therapy. 175516117. 2335139-2. CA12310068. 11083011. CA12440092. > 10 Numbers. CA12440038. 175592713. Sealapex Xpress root canal filling material may contain crystals preventing gutta percha points from reaching bottom.5 or 5cc rather than 30. 2009-03-16 2009-03-16 2009-03-16 2009-02-19 44987 2009-02-10 46551 2009-02-12 46653 Type II Type II Type II Following a long period (> 4 years) without use. IAB-05840-U G) IAK-02691.Lightwave Sensor Zoll AED Plus Defibrillator A) Innova 2100IQ X-Ray Imaging System B) Innova 4100IQ X-Ray Imaging System Datex-Ohmeda AS/3 Anesthesia System A) Button Feeding Tube B) Button Replacement Gastrostomy Device A) Stardriver Screwdriver. 175535293. N/A Manufacturer has determined that the recently manufactured Periowave Photo-Disinfection laser base stations supplied with the plastic base plate (PW1100) do not conform to the current EMC standard. IAB-05840-LWS N/A A) 2335129-4. B) All Lot Numbers which could result in peritonitis and additional adverse conditions. Contact Manufacturer B) > 10 Numbers. CA12440033 A) All Lot Numbers Premature balloon deflation when exerting excessive tightening of the external bolster. in Brilliance iCT systems on software V2. 11111018 N/A Windows does not allow creation of files with same name. chance that fingers can get pinched. 2009-03-16 2009-02-20 46770 Type II Sealapex Xpress A) Universal Intra-Aortic Balloon B) Narrowflex Intra-Aortic Balloon C) 9FR Rediguard IAB Catheter D) 8FR 40cc Rediguard IAB Catheter E) 7FR 30cc Rediguard IAB Catheter Kit F) Ultra IAB Catheter Kit G) Arrow Driveline H) Ultraflex Intra-Aortic Balloon I) Ultra 8 IAB . Zoll Medical Corporation GE Healthcare 2009-03-16 2009-03-16 2009-02-14 46732 2008-09-09 43319 Type II Type III GE Healthcare Finland OY Bard Access Systems. Inc.617. Patient breathing circuit or tubing of the anesthesia delivery unit (ADU) misconnects. Serial Numbers GB8717D5D4 and GB8747303C 1) Possible failure of CIC Pro Alarms. GE Healthcare Finland OY 2009-03-16 2009-03-04 44728 Type II Ventri Dual Detector Cardiac Camera GE Healthcare 2009-03-16 2009-02-11 44732 Type II N/A Galileo Echo Blood Bank Analyzer Immucor Inc. CA12300004. and expiration date.0 ML only) mixer motor can exceed temperature specifications per certain safety standard. 175581661. 2009-03-16 2009-03-03 47005 Type III A) 01803350 B) 01803350 C) 01803350 D) 01803350 A) Fastrac "Pull" Gastric Access Port Kit B) Fastrac Guidewire Gastric Access Kit Bard Access Systems. Contact Manufacturer > 100 Numbers.99 M1057669 6-1314. 7163-8242. Screw kits were distributed containing 2 compression screws instead of 1 each of a compression screw and a lag screw. Monocryl and PDS II sutures in recall #46404.A. Inc. ANBM00367. AED 10 MRS Cemented Stems Siemens Medical Solutions USA. has two contradicting labels: Light-Body Fast Set and Super Fast Set. Smiths Medical MD Inc.N. 073-B002-01.3. Version 1. 10mm diameter MRS Cemented Heads should only be used with the GMRS Distal Femoral Components and the GMRS Proximal Tibial Components.01. 2009-03-16 2009-03-16 2009-03-16 2009-02-17 47050 2009-02-17 47057 2009-02-27 46974 Type III Type III Type II N/A N/A A) 7163-8232. Product was distributed with non-compliant labelling. 100 90 599 10 014 063 970300.0. Howmedica Osteonics Corporation 2009-03-30 2009-03-30 2009-03-30 2009-03-30 2009-02-05 47063 2009-02-11 47068 2009-02-26 47076 2009-03-05 47104 Type III Type III Type I Type II GUI VERSION 4.4. ANAK00114.3.0.3.V. Specimen management rules may fire inconsistently when evaluating tests using nested rules (parent/child). Inc.4 100 90 597. TEC078B Customer safety advisory notice to inform customer of potentially defective stored image data on long term storage. TEC077.4ng/ml. <3. 970311U 6485-3-010.2 REV2. 970309-E. Images from two different patients may be combined in one patient folder in the digital imaging or may be combined as one (printed) image. as well as a very specific sequence of events. M59505. Unable to assure sterility due to a failure in the sterilization process.S. may be impacted. is predisposed to short circuits which can render the keypad inoperable. ANBH00291 E) > 100 Numbers. GUI VERSION 4.5 ug/ml.3.07 And 8. Orthocord Violet Braided Composite Suture Depuy Mitek 2009-03-16 2009-02-03 47042 Type II 223105 AP2546 Instrument Manager Instrument Manager A) Trigen Trochanteric Antegrade Nails B) Trigen Trochanteric Interlocking Nails Intertan Lag/Compression Screw Kit Data Innovations Data Innovations Smith & Nephew. GUI VERSION 4. Low energy delivery 2. Since issuing a recall in December 2008. 9. Contact Manufacturer 1200 > 10 Numbers. 2009-03-30 2009-03-30 2009-02-23 46822 2009-03-09 47011 Type II Type II 990226. The previous patient history and some QA management reports may have missing or incorrect diagnosis text.13 umol/l) with Synchron Systems Gentamicin Reagent (GEN) lot M804552.2. There are no instructions on the package insert for the use of the pinch clamp that is an integral part of the Therasphere Administration Set.07 Or Higher A) 08KM06602. software version 1. may become dislodged rendering Near Empty Alert inoperable. 10315183 N/A 0153-0711 A) N/A B) N/A A) > 10 Numbers. Contact Manufacturer N/A SoftPath GUI v. Axsym Cancer Assay Disk Version 5. In some cases.3. software version 4. The outer packaging of dental impression material. Following the release of the Omnifuse upgrade utility (recall #42817) it was discovered that the options to upgrade French and Dutch language pumps did not correctly install some language text into the pump. Label colour codes and graphics were left off of the outer labels. Secondary package graphic label indicates wrong product (Fusion Extraction Balloon). Siemens Healthcare Diagnostics Inc. Contact Manufacturer C) S/N'S ANAJ00131. 073-A021-01. Loss of voice prompt 4.01. 08KM08612. Smiths Medical has found that one lot of keypads. Shutdown. Problems with the AED 10 defibrillator: 1. 02416873.1. 6485-3-019 N/A > 10 Numbers. 7163-8336. 0131-0236 CFW462190 Contact Manufacturer A) Medfusion Syringe Infusion Pumps B) Medfusion Keypads C) Medfusion Top Case Assembly Specimen Gate Laboratory Smiths Medical MD Inc.4. As this device is distributed in sterile packaging. 08KM07560 B) 08KM12411. Inc. Take 1 Advanced LB Wash Super Fast Set. under certain conditions.1.08 Specimen Management Database Version 8. Electromagnetic noise filtering 5. 4. All other package and internal labelling is correct.2. 6485-3-018. 2009-03-30 2009-03-30 2009-01-22 46162 2009-01-27 46274 Type II Type III A) 70832 B) 708027 A) 06363413. it may result in additional phrases not populating as expected.0. Defect associated with result viewer's "view assay" button in the "specimen history" screen. Two labels were left off package.4.2. P127163 C) M59050. Contact Manufacturer Failure of the electrical portion of the on/standby switch causes the system to shutdown without clinical intervention. Contact Manufacturer B) P120300. and for Advia 1800. ANAK00112. Siemens AG Welch Allyn Protocol. 3500-415 B) G6000607. Contact Manufacturer > 100 Numbers. 970311E. 'Any test is rerun' data element may not trigger a rule to fire even though a test is marked as a rerun in the specimen management database. Caution: device sale restricted to dentists and contains dry natural rubber. 2009-03-16 2009-03-02 46656 Type II A) 1011-9000-000 B) 1011-8302-000 C) 1011-8109-000 D) 1009-9002-000 E) 1009-8134-000 Swan-Ganz Continuous Cardiac Output Edwards Lifesciences LLC 2009-03-16 2009-02-09 46971 Type II 744HF75. Leadscrew & Flag Kits(0131-0236). Inc. ANAJ00133.01. 2009-03-30 2008-02-28 41193 Type I NR7TCSIY All Lot Numbers Wilson-Cook Medical. in some fully assembled pumps and some kits.Trolley C) Aisys Anesthesia Carestation D) GE Datex-Ohmeda Avance Anesthesia System E) GE Datex-Ohmeda Avance Anesthesia System Trolley Datex-Ohmeda. involving patient jacket content.2.A) Aisys Anesthesia Carestation -Main Unit B) Aisys Anesthesia Carestation . The default ratio definition of the calculation for %HBAIC has been confirmed that the calculation is incorrect for Advia 1650.4. Contact Manufacturer > 100 Numbers. 10324237 B) 01412173. Subject suture was impacted by the same sterilization process failure reported for Vicryl. The sample dilution low concentration flag for 1:101 automated dilution protocol fluid for the AxSYM AFP Assay file (3 0 100) on the device allows the instrument to report results between 0ng/ml and 0.0 Abbott Laboratories Diagnostic Division 2009-03-16 2009-03-05 47105 Type III 03D50-05 N/A Elements Gutta Percha Cartridge Take 1 Advanced LB Wash Super Fast Set Sybron Endo Kerr Corporation 2009-03-16 2009-03-16 2009-03-06 47107 2009-03-06 47112 Type III Type III N/A 33955 N/A 8-1182 Navistar RMT Diagnostic/Ablation Catheter Updated recall # 41193 previously posted on 200803-17. Beckman Coulter has confirmed greater variability. Fusion Oasis One Action Stent Near Empty Flags Biosense Webster Inc. ANBL01990. char and coagulum have been observed. . P121344. 7163-8344 B) 71633130. sold in Near Empty Flag Kits(0131-0122) and in Halfnut. 970302E. ANAK00115 D) S/N'S ANBL01967. Inc. for use in Graseby 3000 Syringe Pumps. G6000771 C) G6000737 5002-0180 A) > 10 Numbers. M60280 Version 1. 2009-03-30 2009-03-05 47083 Type II Wallac OY 2009-03-30 2009-01-15 47157 Type II A) 3500-306. and low recovery values on at the low end of the therapeutic range (<1. Certain Near Empty Flags. Contact Manufacturer B) > 10 Numbers. 2009-03-30 2009-03-30 2009-02-24 46763 2009-03-05 47084 Type II Type II FS-OA-10 0131-0122. Laboratories using this feature. Under certain circumstances. 970310E. The product contains Super Fast Set. causing the patient to experience hypoventilation leading to hypoxia. Inc. ANAK00111. which may result in unintended historical image(s) being displayed. the issue may not be immediately evident. when editing text in a report.4 SCC Soft Computer 2009-03-30 2009-01-26 46600 Type II Syngo Dynamics Workstation Software Syngo Imaging C. ANAK00110.Software Omnifuse PCA Syringe Pump Philips Medical Systems Nederland B. Contact Manufacturer TEC231A.3.01. 746HF8 A) S/N'S ANAH001122 & ANAJ00132 B) > 10 Numbers. 08KM06604. 2009-03-16 2009-02-26 46975 Type II Specimen Management Database Version 8. Blown fuse 3.4. The device exhibited characteristics that are inconsistent with the product specifications. 71633134 71677105 Smith & Nephew. Potential patient safety concerns. ANAK00113.3 Therasphere Administration Set Synchron Systems Gentamicin Reagent MDS Nordion Beckman Coulter Inc. 970308E.SPE 469137 N/A M804552 A) Multidiagnost Eleva B) Omnidiagnost Eleva A) Advia 1650 B) Advia 1800 Centricity PACS Workstation . 08KM12403 06GM11410 Cardiac output measurements were unavailable and the following fault message was displayed in vigilance monitors: "fault. GUI VERSION 4.4. CCO catheter verification use bolus mode" instead of continuous output mode. 2009-03-30 2009-03-30 2009-03-09 47191 2009-03-09 47200 Type II Type III GE Healthcare Integrated IT Solutions Smiths Medical MD Inc. There are no warnings on the label or IFU that the 8. Abbott Point Of Care Inc. 1012. A) N/A B) 6001607001 A) > 10 Numbers. T2. Inc. Oncology Care Systems 2009-03-30 2009-02-26 47066 Type III A) 000957. affects when using console versions CC6.5 Cannulated Hex Screwdriver B) Wright Express Kit Architect Reaction Vessels Truncated Blade I-STAT EG7+ Cartridges Flow-Set Fluorospheres Brainlab AG 2009-03-30 2009-02-03 46474 Type II A) 00-6428-028-01. 00-6428-032-02. Contact Manufacturer 60682170 P08274A 7524003F. 7524005F. The manufacturer has noticed an increase in the number of complaints of snare (loop) detachment from the device. Cracks can form around the screw connections of the cover plates and the material can become brittle and fragments break off. 2009-03-30 2009-02-23 47128 Type II A) Radiolucent Spine Reference Clamp Kit B) Radiolucent Spine Reference Clamp A) Darco 2. 000465. 000476. 000479 C) FESG20ND D) FESP20ND E) FEXG20ND F) FEXP20ND 1940035. The pinion gear could crack and may cause damage to the systems. Current flow set labelling does not provide new target settings for tetra applications. 200599. 000963. A combination of Spine Reference Clamp(55756) with any other array or extension then the intended array(55753). 000983. A) Disposable Singular Polypectomy Snares B) Disposable Optimizer Polypectomy Snare C) Entake Peg Push Safety Kit D) Entake Peg Pull Safety Kit E) Entake Peg Push Standard Kit F) Entake Peg Pull Standard Kit Conmed Endoscopic Technologies. 000474. Contact Manufacturer > 50 Numbers. 200593. There is the possibility that the performance of the cartridge assay may be impacted. 000979. 000478. 006428-028-03 B) 00-6428-032-01. If the last image stored is an elastogram. 000473. 000964. it may appear as the first image of the next patient. 000463. 10275010 1056. A) Alumina Ceramic Femoral Head 28mm B) Alumina Ceramic Femoral Head 32mm Zimmer Inc. 000992 B) 000460. 000466.1. Replacement of the pinion gear is mandatory. 200583. 00-6428-028-02. 000977. 4504200 A) 0605011 Through/Including 0805311 B) 0605011 Through/Including 0805311 C) 0605011 Through/Including 0805311 D) 0605011 Through/Including 0805311 E) 0605011 Through/Including 0805311 F) 0605011 Through/Including 0805311. 000980. ILED5. 0807161 Through / Including 0811202 3235. 000988. 10275008. 200334 Safety advisory letter concerning the apparent inconsistency in the direction of gantry rotation during an auto-sequenced delivery. T16 Siemens Medical Solutions USA. Certain boxes of i-STAT EG7+ Cartridges have sub optimal pouch seals. haven't been validated for this instrument. 000985. 000987. 2 of 3 sterilization methods (by gravity displacement) listed in package insert for Darco Cannulated Hex Screwdriver. Beckman Coulter Inc. Labelling for the applicable case Zimaloy/cobalt-chrome hip stems will also be changed. 000986. Contact Manufacturer B) > 10 Numbers. error code 1007 and incorrect patient results. 000978. Molecular Imaging Group 2009-03-30 2009-02-26 47218 Type II 10275007.ILED Surgical Lighting Systems Trumpf Kreuzer Medizin Systeme GMBH & Co. 1058 The cover plates on these surgical lights can be damaged by certain disinfectants. 3645 Acuson S2000 Siemens Medical Solutions USA. 2009-03-30 2009-02-24 47069 Type III 10041461 200288. 000965. allows for rotation of the reference array even though the mounting nut is tightly closed. 000467. The incorrect catalogue number corresponds to full blade. 000462. Inc. 000477. ILED5K 100268621 to 100717475 Symbia T. 000984. 2009-03-30 2008-12-04 45614 Type II Linear Accellerators Siemens Medical Solutions USA. 000461. 006428-032-03 A) 55757 B) 55756 A) DC4261 B) DMRSKIT1 7C15-01 00-7053-058-10 N/A 6607007 A) All Lot Numbers B) All Lot Numbers Labelling will be changing to indicate that these heads should not be combined with Zimaloy hip stems made from castings. 000472. Data framing an image could be leftover from a previous patient and may or may not include measurement results. T6. KG 2009-03-30 2009-03-16 47210 Type II ILED3. 7524004F. 7524006F Wright Medical Technology Inc. Reaction Vessels manufactured from a specific lot of resin have an increased likelihood of producing error code 1006.2 through CC9. 000991. 2009-03-30 2009-03-30 2009-03-30 2009-04-13 2009-03-04 47027 2009-03-12 47373 2009-02-23 47216 2009-03-16 47347 Type III Type II Type II Type II . 1. Inc. 2009-03-30 2009-02-19 46951 Type III Abbott Laboratories Diagnostic Division Zimmer Trabecular Metal Technology. 3356. 200591. 200252. Inc. Inc. sold alone and as part of the Wright Express Kit. 000464. Damage to the pinion gear may cause the gantry to spin freely. 000959. 3236. The catalogue number etched on the instrument reads "7053-58-20" and it should read "7053-58-10". 000475.2. 000958. 000960. 1550 Electric Stetcher With Quick Drop Stryker Medical 2009-04-13 2009-03-16 47353 Type II 1550-000-000 C2A Ringloc Acetabular System . RESH0255. CL-07080. CL-07780. CL-08803. 0706. 010-1655-00 22125701. 2009-04-13 2009-04-06 47692 Type III 442745. Label indicates a length of sample notch of 1. CA-09803. 3787 B) 3704. 2009-04-13 2009-02-18 46908 Type II Access Systems Total BHCG Reagent Kit Beckman Coulter Inc. CL.A) Percutaneous Sheath Procedural Kits B) Central Venous Catheterization Set/Kit C) Temporary Pacing Catheter D) Two-lumen Central Catheterization Kit E) Percutaneous Sheath Introducer Sets F) Stopcocks G) Arterial Access Products H) Thrombolic Device Rotator Drive Unit I) Tretorola Percutaneous Thombolic Device J) Percutaneous Sheath Introducer K) Super Arrow-Flex Percut Sheath Intro L) Stopcock with Luer Lock M) Stopcock Manifold N) Multi-Lumen Percut Sheath Introducer O) Stopcock with Luer Lock P) Stopcock with Luer Lock Q) Blood Administration Sets R) Extension Sets S) Trerotola Percut. CP-08803. If the stretcher continues to be used. CP-08903. RESH0057. Contact Manufacturer During the attempted removal of the device. Audio alarms continue to function normally.8cm (18mm). The foil wrapper for specific lots of slide cartridges may have been damaged during the packaging process. CL08603. 37043B. CL07735. 0724.Enzymatic CO2 C) Vitros Chemistry Slides . CL-07690. Hill-ROM Company. 0709. 410-205. where actual RESI0451 product is 1. 2009-04-13 2009-04-13 2009-02-20 46721 2009-02-24 47393 Type II Type II A) 771290064484 B) 771290064491 A) 3706. CA-09807. A metabolite of naproxen. 410-112. M808354 . SB.Total Bilirubin Beckman Coulter Inc. AA-15511-S. CP-08603. CL07635. has demonstrated a positive interference with the Jendrassik-Grof method of measuring Total Bilirubin. O-desmethylnaproxen. 0703. 2009-04-13 2009-04-13 2009-04-13 2009-04-13 2009-03-16 47389 2009-03-09 47251 2009-03-09 47219 2009-03-17 47238 Type II Type II Type II Type II 12-115112(RD115112) MC1810. Incorrect label. CP-08603P. AA-15511. 37043. 410-203. This may produce a shift in results. CL-07800. CL-07880. CL08703. Inc. Also Trading As: Biomet Microfixation Ace Surgical Supply Co. MTO-09801CHA K) CL-08403. MC1816. RESI0279. 3706 01-0267 34630 There is an increase in background relative light units (RLU) when comparing results between when a pack is first mixed/loaded and after it has settled on the instrument for 10 hours or more. N/A Toothbrush head may pose a choking or swallowing hazard to children under three years of age or to individuals that would normally require supervision or assistance brushing their teeth. 6276-1-325 410-111. K) Contact Manufacturer L) Contact Manufacturer CL-07700. CL-07824. CL-07511. 0712. 0727. Inc. CL-07045.0x6mm Self Drilling 5/0 Polyglycolic Acid Absorbable Suture Uniprix Inc. Inc. Inc. A) 10380.Creatine B) Vitros Chemistry Slides . the fowler may inadvertently drop to its lowest (flat) position.Stryker Ireland Boston Scientific Corporation 2009-04-13 2009-04-13 2009-03-27 47576 2009-03-23 47581 Type II Type II 6276-1-121.28 mm Bard Max-Core Disposable Biopsy Instr. 825652 Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution. Norwex Enviro Products Inc. B) All lots between 6892 and 8180 91807107 081031-07 The 01-0267 Byrd screw may break when being used. 21883201. 410-126. AA-15611-S. 3705C. CL-07524. MC1820 N/A 22963 A) Option + Sterile PADS 5cm X 5cm B) Option + Steriles PADS 10cmX10cm A) Heparin pre-filled syringes B) Saline pre-filled syringes Byrd Screw 2. M) Contact Manufacturer CL-07790-R.N) Contact Manufacturer 07835. The Phosphorus Reagent (PHOSm) may fail calibration approximately three to six days after loading on some Synchron systems. Exposure of slides to uncontrolled environmental conditions could impact performance. 2009-04-13 2009-03-16 47348 Type II A) Contact Manufacturer A) AK-09903-J. RV-09803. CA-09886. Inc. 21834602. IC-09880 L) W20041 33500 824542. CP-07811. CW-08803. AA-15624 H) PT-65509-HFC I) PT-45509 J) CA-09801. Inc. CL-07924. Restoration Modular Cone Bodies Percutaneous Combination Stent Howmedica Osteonics . 2009-04-13 2009-04-13 2009-03-13 47475 2009-03-29 47632 Type III Type II Walter Lorenz Surgical. leading to spurious elevation in Total Biliruben levels. Bard Peripheral Vascular. CA-09903-LF. 6276-1-219. CL-071165. W-19922 G) AA-00611. A small and limited number of packaged product demonstrated a partial delamination. CL-07611. causing the display to go blank. 476861 Synchron Phosphorus (PHOSm) Reagent A) Vitros Chemistry Slides . Hill ROM Totalcare Bed Norwex Silvercare Toothbrush Biomet Orthopedics. 2009-04-13 2009-04-13 2009-04-06 47693 2009-03-31 47712 Type III Type III 467868 A) 680 2584 B) 8262396 C) 8208431 D) 8159931 M808353. CL-07724. O) Contact Manufacturer P) Contact Manufacturer CL-07965. Thrombolytic Kit Arrow International. CL-07024. CP08403. a potential difference of 1mm in length. CR-07745 S) Contact Manufacturer F) SC-00001. B) 10381 A) All lots between 6892 and 8180 Complaints received about discolouration and particulate matter contamination. Medical Flat Panel Power Supply Spacelabs Medical. 3780. CP-07711. 3705NC. CP-07611. 410-202. 410-207.9cm (19mm). 2009-04-13 2009-03-25 47582 Type II 0647. W-15549. CL-08503-A. CL-07980. Medxl Inc. CW08703.CSF Protein D) Vitros Chemistry Slides . 0728. Ortho-Clinical Diagnostics Inc. CL-08705-HF.G) Contact Manufacturer H) Contact Manufacturer 07065. 6276-1-125. There may be deterioration of short or long term packaging integrity (inner or outer) with potential loss of sterility. CP-08503. AA-15611. CL-07765. All Lots Possibility of ceramic heads fracturing with +5mm offset. Contact Manufacturer Stretcher fowlers (backrests) may develop a grinding noise from wear of drive nut threads in the fowler. CL-07665. 410-304. 410-204. CL-07624. CL-07711. In one instance surgical intervention was opted to remove a suture. 3786. 3781. SP-09801 D) Contact Manufacturer B) AK-14703-J. AM-15703-J E) Contact Manufacturer C) AI-06210-IK. 410-206. 410-305 010-1619-00. 0732 N/A Synchron System Total Bilirubin Reagent Beckman Coulter Inc. CL. > 100 Numbers. or coming apart. Q) Contact Manufacturer R) Contact Manufacturer CP-07911. SB-09907-S. CL-08605-HF. SB-09803. CP-07011. AI-7155-IK F) Contact Manufacturer D) AK-17702-J E) CL-07011. CL-08605. CP07511. CL-07545.B) Contact Manufacturer C) Contact Manufacturer 09883-S. of the two layers of material that make up the clear portion of the outer packaging. 10381 Some sterile pads that had not been sterilized were released for sale. 37043BNC. Packaging test logs indicate burst test results fell below validation parameters. The external power supply used with certain models of the Spacelabs Medical 19" flat panel displays may fail prematurely. 21883401 > 100 Numbers. CL-07645. It could cause the e-ring to be missing and could result in an inability to latch the siderail. 0707. sutures were separated from the catheter and remained in the patient. J329AMXXX to J340AM1369 E-ring may not fully be seated on the siderail bracket. CL-07845. CL-07745. Inc. I) Contact Manufacturer J) Contact Manufacturer CL-07590. RESH0736. CL-08503. CL071180. CP-08703. CR-07645. Philips Medical Systems Philips Medical Systems 2009-04-27 2009-04-27 2009-04-27 2009-04-02 47834 2009-04-09 47915 2009-04-09 47916 Type I Type II Type II The Sterrad 50 system may potentially have defective oil fill plugs. The therapy switch has a small potential to fail. 10 014 155 B) 8462645 510998. Siemens Medical Solutions USA.thereby increasing the probability of inappropriate therapy.52 B) 704. MMT-382600 SXR0602021. Investigation for occlusion/no flow identified that disks involved in the low pressure check valve to have not been polyisoprene coated. 2010+ 3026-0010. C1820B. VV8. > 10 Numbers. due to degradation of a low-voltage capacitor. instead of 0. 95248. H-199 B) T165.0 Server Software B) Syngo Dynamics SD 6. WW8. T177 122-719 All Manufactured Between 2003-2008 LN 081219511 and 081219512. 25mm length files were mislabeled as 21mm (SXR0602021). 10 014 154. MPC Microscissors B) Vertical Scissors Update Recall # 35431 previously posted on 200706-11. LN 081223510 and 081223511. MIC (Minimum Inhibitory Concentration) result interpretation can be corrupted and an antibiogram could be reported as sensitive instead of resistant or vice versa. can contribute to emission of oil mist from the sterilizer. The truncated V-Bottomed Microplates delivered as a package of 10 plates may have occasional contamination which results in an apparent elevated C4 concentration in an affected well. C1813B. 617093. 620 PCS2 Harness Set Coloplast A/S Haemonetics Corporation 2009-04-27 2009-04-27 2009-01-23 46373 2009-04-13 47918 Type II Type III AG55XX 00620-00 Wizard Replacement Gastrostomy Device Bard Access Systems. TT8. Technidata S. . F69429 B) F61426. MM9. results in expiratory valve staying in the open position. 00205W. 511590 A) 61028769. contoured advance seat. The belts are used in the James Leckey seating systems: mobile advance seat. They may contain the incorrect fuse for the electrical configuration at the customer site. 616520. Potential for reduced ERI to EOL time in a subset of implantable defibrillators. 616521. Remote hazard of serious adverse health consequences. Degradation of the nylon 6-6 plugs over time. F65194. 92241. A) N/A B) N/A C) N/A D) N/A A) N/A B) N/A LEC/019910-LEC/043681 Right ventricular lead complications may cause additional over-sensing . 352165. Holter software version 2. rendering it unusable for monitoring and defibrillation therapy. 2009-04-27 2009-02-03 46562 Type III A) 100 90 370.0 reporting system. T167. 6424779 C1410A.9 and 2. may cause damage to the inner wall of the blood vessel. rendering the device unstable until power is restored. C2013B. 2009-04-13 2009-04-01 47695 Type II > 10 Numbers. A Division Of Ethicon 2009-04-27 2009-03-13 47825 Type II A) 626002 B) 626002C C) 626002C-M D) 626003 E) 626003M F) 626003X G) 626002M A) 10050 B) 10033 TD-SYN-01 M4735A M3535A. 6424704. T175. Contact Manufacturer Servo 300 Maquet Critical Care AB 2009-04-13 2009-03-27 47623 Type II Truguide Coaxial Biopsy Needle Bard Peripheral Vascular. rendering it unsuitable for bypass graft. UU8. Braun Medical Inc. H-197.9. LN 081224510 to 081224512 > 10 Numbers. Black circle on pouch label for C2013B stated "for use with Bard MaxCore or Monopty Instruments". A premature failure of the stitching at the junction of the shoulder strap and the sling body can lead to the detachment of the shoulder strap resulting in possible patient fall. 00214W. 2009-04-27 2009-04-03 47789 Type II Advanced Sterilization Products. squiggles saddle seat. F58670. 00207W. Printed circuit boards have stopped working. Under certain circumstances.52 A) 10 014 142. 00202W. 3026-0030 A) 95243. A) Magic Store System B) Sienet Magicstore A) Syngo Dynamics SD 6. The failure may also occur by spontaneously powering on. 6079433. 00224W A) N106 B) N107 C) E102 D) E110 A) H-190. XX8. 352166. Contact Manufacturer Difficulty inserting or removing the feeding adapter cannula into the device. 2 Ultrasite B) Primary IV Set with 3 Ultrasite A) Grieshaber Handpiece. rather than a smooth rounded point. 617090. 617094. 515079. 00223W. sometimes preceded by a short valve closure. The macro component intended to be used with the Factor II G20210A Kit for LightCycler 2. C1810B. 616523 073008100. 352168 6079300. 61028767 B) 61029904. when editing text in a report. The rotary energy switch may fail and prevent the user from turning the device on. LN 081222510 and 081222511. 6150614.3 units of U-100 insulin. Inc.0 Workstation Software A) Cell-Dyn 3700 SL Analyzer B) Cell-Dyn 3700 CS Analyzer Holter Neogram Amino Acids Mass Spec Kit Wallac OY B. Inc. 3904115986 Manufacturing defect consisting of a rough square finish to the scissor tips. C2020B MMT-377600.A. Inc. Alcon Grieshabe AG Siemens AG 2009-04-27 2009-04-27 2009-04-27 2009-04-27 2009-03-26 47713 2009-03-27 47750 2009-04-06 47782 2007-05-24 35431 Type III Type II Type II Type III 6003-0020 A) 352049/CSP152VSL B) 352049. C1816B. Contact Manufacturer Paradigm Silhouette Infusion Sets Unomedical A/S 2009-04-13 2009-04-01 47734 Type II 617095. IFU tells users to fill empty space in the cannula with a fixed prime volume of 0.7 units. 00215W. Most likely failure mode is spontaneous turnon which could deplete the battery. 617089. Product recall due to the possibility that the device tip could break during use. 062608322 All Lots GT Series X Factor II (Prothrombin) G20210A Kit Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Roche Molecular Systems. 616522. F63004 A) 3901384286 B) 3904116228.1 may contain problems which could affect its performance. 6079391. squiggles early sitting system. if exposed to hydrogen peroxide. 61029908 A) F53125. Some tracer bottles in the Delfia Xpress PAPP-A kit have bar codes which cannot be read in the Delfia Xpress instrument. 352167. 93901 B) 93477 A) All Serial Numbers B) All Serial Numbers N/A Contact Manufacturer Abbott Laboratories Diagnostic Division Philips Medical Systems Wallac OY 2009-04-27 2009-04-27 2009-04-27 2009-04-01 47694 2009-03-30 47704 2009-04-01 47714 Type III Type II Type II A) Combi Sling B) Combi Sling Deluxe Child C) Combi Sling Mesh Deluxe Child D) Combi Sling Deluxe Oversize E) Combi Sling Mesh Deluxe Oversize F) Combi Sling Oversize Heavy Duty G) Combi Sling Mesh Deluxe A) Sterrad 50 Sterilizer System B) Sterrad NX Sterilizer System TD-Synergy Software On TD-Microbiology Heartstart XL Heartstart MRX Defibrillator / Monitor BHM Medical Inc. These new metal cannula may have a tolerance stack up issue with selected lots of these scissors.0 instrument may erroneously identify the C20209T mutation as a wild-type genotype instead of an unknown genotype. and 21mm length files were mislabeled as 25 mm (SXR0602025). Inc 2009-04-13 2009-04-27 2009-03-30 47759 2009-04-06 47434 Type III Type III Delfia Xpress PAPP-A A) IV Set with Universal Spike. 00204W. There have been occurrences of visible fire and smoke from the analyzer.S. F67471. MMT381600. it may result in additional phrases not populating as expected. A typographical error in the fixed prime volume listed in instructions for use.Coronary Scissors 7" Teleflex Medical 2009-04-13 2009-03-09 47208 Type II 352164. SS8. 2009-04-27 2009-01-16 46066 Type II A) Cognis CRT-D HE B) Cognis CRT-D C) Teligen ICD (VR-HE DF1) D) Teligen ICD (DR-HE IS-1) A) Contak Renewal 4 CRT-D B) Vitality 2 Acid Leckey Four-Point Pelvic Harness Cardiac Pacemakers Incorporated 2009-04-27 2009-04-03 47936 Type II Cardiac Pacemakers Incorporated Leckey (James Leckey Design) 2009-05-11 2009-05-11 2009-03-04 47031 2009-04-15 47922 Type II Type II 00201W. Contact Manufacturer B) > 10 Numbers. C2016B. SXR0602025 3610195001 Date Codes RR8. The central plastic buckle degrades and can fail in use. Hardware component is near end of expected life cycle and the RAID Controller can cause a system crash resulting in a loss of data. 375100 A) 705. 100 90 480 B) 100 90 257 A) 02H31-01 B) 02H30-01 1810. Philips Bougies List No. instead of "for use with MAGNUM Instruments and Biopsy Needles or Biopty Instrument and Biopty-Cut Needles". This recall is the result of reports of leaks at the blood filter of the Haemonetics lN620 PCS2 Plasma Harness Set. New metal cannula assemblies are scheduled for launch in June 2009. M3536A A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A A) > 10 Numbers. Contact Manufacturer N/A S/N US00442485 to US00469873 S/N US00210406 TO US00333123 There is potential issue in the syngo Dynamics 6. MMT-378600. F4MX8C. 83576 B) SN 91129 >10 Numbers. E4MH18 C) E4MJ3K. DISCOVERY-WI B) EXPLORER LP 12 Focal SIM 9027. patients with non-transmitted esophageal contractions that have been acquired with this software. Contact Manufacturer N/A N/A Integra CEM Premier Dental Products Company DBA Premier Medical Medmont PTY Ltd.0. DYND50425. 60206. 60332. DYND50421. A waveform signal cannot be detected. E4ML6J. Computerized Medical Systems Getinge Disinfection AB 2009-05-11 2009-05-11 2009-05-11 2009-04-09 48000 2009-04-09 48015 2009-04-20 48035 Type II Type II Type II A) DISCOVERY-A. LXI034500 N/A Affected defibrillator /monitors may have a solder defect on the H bridge component that could prevent the device from providing a defibrillation shock. DISCOVERY-W. Beckman Coulter Inc. 83318. 2009-05-11 2009-04-02 47888 Type II 87000 Infinity Glucose Hexokinase Reagent Acuson S2000 Fisher Diagnostics. 2009-05-11 2009-03-25 48059 Type II 3001410 All Lots A) E300 Corneal Topographer B) DV2000 Digital Imaging Software C) M700 Automated Perimeter Quickie LXI Manual Wheelchair 2009-05-11 2009-03-10 45746 Type II Sunrise Mobility Products Division 2009-05-11 2009-02-02 47380 Type II A) N/A B) N/A C) M700 LXI A) >10 Numbers. 64141. 64137. Unlicensed class II medical device. Sale or distribution of the Integra CEM (item #3001410) is in violation of the medical devices regulations. the report may incorrectly report the esophageal contraction results. 2009-05-11 2009-04-27 48114 Type II 4002. Contact Manufacturer B) >10 Numbers. The Integra CEM is not licensed as required per section 26 of the medical devices regulations. LXI-034609. Inc. 83024. Two lots of product are affected in this issue. 3550-0907-0220. 60422 B) 64032. DYND50424. 200926. A drain placed by a surgeon and an x-ray ordered. 35501106-0148 121808304 A) >1000 Numbers. Stabilizer bar adds rigidity to the back to reduce head movement should the chair be involved in a vehicular collision. and Microsoft hotfix. 4003 S/N: 3000033364 to 3000038740 Insight Rev H Software-GI Motility System Sandhill Scientific Inc. A series of events could cause the last image to be stored with the next new patient performed. bolus monitoring. 2009-05-11 2009-04-17 47998 Type II Lifepak 12 Defibrillator / Monitor Focal Software CD Washer Didinfector Getinge 9027 . DYND50422. Unicel DXC 600I Synchron Access Systems Beckman Coulter Inc. The frame earth of the supply transformers for Getinge 9100 and 9027-series Washer Disinfector have burnt out. but an audible signal and the computer screen indicate the x-ray is off. Inc. . 64049. Contact Manufacturer LXI-034741. During examination of shelf life samples as part of real time shelf life validation. 200995 SmartMonitor 2 Infant Apnea Monitor Respironics Inc. AW hangup). LXI-034740.A) Endopath Endoscopic Linear Cutters B) Endopath Endoscopic Linear Cutters C) Endopath Endoscopic Linear Cutters Eccentric Bushes In-Situ Bender/Cutter Synchron Systems Ammonia (AMM) Reagent A) Somatom Definition B) Somatom Definition AS Ethicon Endo-Surgery. L Teslia Mass 2 measurement label appears in the report in English only. LLC Siemens Medical Solutions USA. Contact Manufacturer 313288. 64069. 64316 Software V.521S. Inc. 64306. 3550-0207-0179. E4MT4Y B) E4MH2L. 64052. Inc.522S 439770 A) 77 40 769 B) 8098027 A) E4MM23. 64233. E4MG9M. more than 4 measurements may print. This only occurs when manually ordering an assay using the run test wizard on instrument with bidirectional interface capability. Failure of product to meet the stated performance specifications for shelf life. Incorrect patient demographic information could be associated with a sample ID. The Vumax Ophthalmic Ultrasound System may. Inc. E4MP4A. under certain circumstances. 530. 2009-05-11 2009-05-11 2009-04-09 47989 2009-04-14 48076 Type II Type III TR15498 10041461 V28015 200252. 200979. 3550-0108-0244. The ammonia reagent may fail calibration or cause a low shift in quality control recovery (may recover below the limits of the established range) on some Synchron systems. resulting in linearity of less than the stated specifications. Siemens Medical Solutions USA. 83336. kernel changes. Inc. When performing a tee exam with the V5MS Transducer. Software V. patient delete.3. 3550-0408-0258. 2009-05-25 2009-04-21 48072 Type II Acuson S2000 VA10 Siemens Medical Solutions USA. 83792. 3550-0908-0278.535.9100 Physio-Control.0 The mechanism which connects the articulation joint to the device shaft may be insufficient. 2009-05-11 2009-05-11 2009-04-06 48008 2009-03-10 47844 Type III Type III PUSURG1 A) 8015 B) 8120 10348531 3550-0207-0178. Potential risk when the Alaris PCA Module is used with the Alaris PC Unit. 313273 Prototype tips were mistakenly distributed to customers. Swiftlink adapters manufactured prior to October 2008 can cause a failure that results in image quality when using Acunav catheter transducers that does not support intra-cardiac diagnosis or procedure guidance. A Division Of Fisher Scientific CO. a program is sent by the LIS only to the DXC console and the sample will not be processed at the access 2I. graphic driver. Siemens AG 2009-05-11 2009-05-11 2009-05-11 2009-05-11 2009-01-18 47039 2009-04-09 47833 2009-04-08 47835 2009-04-14 47910 Type III Type II Type II Type III A) LONG45A B) ATB45. the company became aware of and confirmed a breach of the sterile pouch barrier. 83053. 60348. 60235. Setup reference point incorrectly defined for prone patients when manual shifts are used. 2009-05-25 2009-04-14 48077 Type II DYND50420. 35500707-0215. CW (continuous wave) mode is not functional. 3D intervention. 3550-1106-0147. 05AA0001-09CA9999 DYND50423. DISCOVERY-C.4. Gallileo Echo Blood Bank Analyzer Immucor Inc. Result from investigation shows poor connection between incoming and outgoing Protective Earth. 64238. DYND50426 10041461 200334. 60199. the drain did not show up on x-ray although the packaging states the product is x-ray opaque. 3550-01080252. 3550-0708-0271. 2009-05-11 2009-04-14 47926 Type III A27318 Vumax Ophthalmic Ultrasound Scanner Sonomed Inc.4692 530. 2009-05-11 2009-04-07 47911 Type III A) Discovery X-Ray Bone Densitometer B) Explorer X-Ray Bone Densitometer Hologic. In rare instances. The Alaris PCA Module can potentially infuse above or below the intended infusion dose for a specific sequence of events. 313171. In HRIM or EFT. A nonconformance with the Eccentric Bushes can result in a rough surface that will result in altered revolutions per minute(RPM) and the lifetime of the device. Update the software on bugfixes (i-triggered sequence. 200288 VGM 19" Monitor Viewsonic Corporation 2009-05-25 2009-04-21 48079 Type II VG930M S/NS > QC2082880001 Stabilizer bar was inadvertently omitted from the configuration due to a system error. Contact Manufacturer C) >10 Numbers. This may cause the jaws of some of the affected Endoscopic Linear Cutters to remain closed and clamped down on tissue. 9100 A) S/N: 83232. If a sample is manually loaded to the access 2I and no program is at the access 2I or DXC console. 83760. reconstruction of raw data. 82888. 3550-02070177.0. This event occurs on every attempt to acquire a CW signal. return measurement values on the order of 1/2 or 2x the actual value.06E. 2009-05-25 2009-02-23 47672 Type III S98-1925-2H All Lots Medline Penrose Drain Medline Industries Inc. This can result in a situation where the alarm will not sound. LLC 2009-05-11 2009-04-08 47966 Type II Kaltenbach & Voight GMBH Synthes (Canada) Ltd. 3D recon. 2009-05-11 2009-04-13 47987 Type II SHFS35-S Proultra Surgical Endo Tip A) Alaris PC Unit B) Alaris PCA Module Acuson X300 PE Swiftlink Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Cardinal Health 303. the system does not turn the x-rays off at the end of a DXA scan. F4N799 N/A All Lots M808278 A) 60148. 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel. Root cause is a software conflict within software version V2. Contact Manufacturer B) >1000 Numbers. DISCOVERY-CI. The "x-ray on" indicator light remains on. A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. ATW45 C) NAW45 0. 3550-0908-0277. 3550-0707-0213. 2009-06-08 2009-06-08 2009-05-08 48241 2009-05-06 48337 Type III Type II 4476433190 00-4450-054-00. Oncology Care Systems Motion Concepts LP Siemens Medical Solutions USA. 10275010 B) 08717741 03009696001. 1159 >10 Numbers. The 09-0142. This degradation results in film strength properties below the ASTM performance standard for surgeon's gloves. 1199.Stryker Ireland Abbott Point Of Care Inc. WR-04. the preventive maintenance measures. 279. 70185600. 5570-T-080 A) 00-5964-014-51. 68365. 68328. WU-02. 69291 D) 68444.8 µmol/l) to 20 mg/dl (342 µmol/l) icterus index for the Roche/Hitachi acetaminophen assay. when editing text in a report. Advisory reiterating to customers the potential for the adaptor trial to seize. 55. 584 Poor or intermittent connections. 454-1210 100 90 480 A) 10024 B) 10040 A) >10 Numbers. Inc. 54558. Waste Bottle For ABL7XX And 8XX Flex Radiometer Medical APS 2009-05-25 2009-04-30 48225 Type II D512 (905-590). 219.1 reporting system. 0020. 00-4450-058-00. WR-03. Reports received that when the battery pack is first installed in pump. 1153. 70193000. 15068201. WU-05. WS-02. Contact Manufacturer 92172-1 08H599H. 0193. 00-4450-063-00 A) All Lots B) All Lots C) All Lots 0013. it may result in additional phrases not populating as expected. 39. if the beam plan is edited. 0144. waste material may leak both from the analyzer and from the waste bottle. 1012 B) 1143. Inc. 1112. Improvements of Echo software since the 1. 01200 Pneumo Sure XL High Flow Insufflator 09-0142.2. WS-03. 1018. 10275008. 2009-05-25 2009-05-25 2009-05-25 2009-05-25 2009-04-23 48206 2009-04-27 48207 2009-04-27 48245 2009-03-16 47349 Type II Type II Type II Type II A) 61219714. 68330. 68335. 69281. CADD-SOLIS Rechargeable Battery Pack Smiths Medical MD Inc.SN10006093) may fail. 2009-05-25 2009-05-25 2009-05-25 2009-05-25 2009-05-25 2009-04-21 48254 2009-02-19 46283 2009-02-05 46559 2009-02-13 46601 2009-03-04 47064 Type III Type II Type III Type III Type III A) 08162807 B) 08162815 A) N/A B) N/A N/A 454-0210. WY-01 A) 1103. Inc. 08J175J >10 Numbers. 902106 The insulin pump (numbers SN02053575 . The rechargeable battery pack can overheat with or without the presence of smoke causing the Martel printer to overheat in the i-STAT 1 analyzer system. Contact Manufacturer Terumo Cardiovascular Systems Corp. the pump will not power up or an alarm sounds and an error message displays indicating that battery pack is unusable and pump will not run. 03265439001 For 905-590/D512 : WR-01. Contact Manufacturer All Lot Numbers N/A Possibility of stress related cracks occurring in our power elevating seat actuator models as the result of atypical or extreme usage of the wheelchair seating system. When all plans are loaded on the device. Inc. 1056. 65685 SN02053575 to SN10006093 Nexcare Opticlude Orthoptic Eye Patch 3M Canada Company 2009-05-25 2009-05-05 48185 Type III 900605. 0396. 68366. 57395 C) 68153. Due to several root causes leading to missing or mislinked Performed Procedure Step's some or all studies of a patient may become inaccessible from Syngo studio. 0601 Screws in the power manager board may come loose and come into contact with system 1 chassis. WS-02. WU-03. 263. The claim for significant bilirubin interference decreases from 28 mg/dl (478. 04759702001. WR-02. WU-06. Dean Scissors Roche/Hitachi Acetaminophen Assay Triathlon Offset Adaptor Trials Stryker Endoscopy Walter Lorenz Surgical. 902007. sometimes "study merge" does not work. accessory information in the lantis can be potentially overwritten or removed. Immucor Inc. as stated in the package insert. There is potential issue in the Syngo Dynamics 5. 2009-05-25 2009-04-30 48233 Type III 21-2160-51 >10 Numbers. A) Nexgen LPS B) Nexgen LPS-Flex Femoral Components Austin Moore Stems . These items may possess a nonconforming finish on the polished surfaces which could potentially increase wear and decrease the product life cycle on the articulated surface. making it difficult to remove. 2009-06-08 2009-06-08 2009-06-08 2009-01-12 46050 2009-01-29 46444 2009-04-27 48195 Type II Type II Type II Folate III Reagent Kit TransFx Drill Bit Roche Diagnostics GMBH Zimmer Inc. Under certain circumstances. 10275007. WU-03 For 905-802/D513 : WR-01. 10275009. WU01. Inc. 1193. Terumo Cardiovascular Systems Corp. 68217. 68368. 1058. Contact Manufacturer Possibility a patient injury can occur when the patient is lying on the patient bed and the automatic collimator changer is undergoing a collimator change operation even when the patient bed is retracted. 61204820 B) 61207901 LOIINRA >100 Numbers. 2009-05-25 2009-04-02 47909 Type III A) 82 45 875 B) 8255412. Insufflators are powering off during surgery or not powering up completely. 70205400 . With a 3rd party RIS. This failure may present an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation. WR-03. when editing text in a report. 5570-T-060. reducing the efficiency of drilling action. information for instruments interfaced to laboratory information system. WS-01.1. In rare cases the trigger wire can become damaged and then compressed between the stent and the top cap. 15127201 Certain lots of the Folate III Reagent Kit may induce an elevated recovery of folate in liheparin plasma. 63210 B) 53418. 1128. 220. 0810006705 Some gloves may be discoloured as a result of film degradation. 61377. WS-01.2 SPF Reporting Workstation Orthos CM Bracket Syngo Dynamics Server Software Siemens Medical Solutions USA. 0017. 56454683. To inform our customers of a potential software problem with the Acuson Sequoia Ultrasound System that may result in overheating of the auxiliary 2 mHz continuous wave (CW) transducer. to address the recalls previously N/A initiated: duplicate alphabetical sample barcodes. When removing the waste bottle from the analyzer. Dean Scissors are breaking when used. 00-4450-056-00. WS-04. 04759729001 1539 Disetronic Medical Systems AG 2009-05-25 2009-04-17 48163 Type II A) 53736. WU-02. 08J174J. and risk mitigation measures. Potential situation where the test validation ranges configured in the process systems managers (PSM) can incorrectly release a patient result where there are multiple reference ranges defined.1. Contact Manufacturer A) Acuson Sequoia 512 Ultrasound System B) Acuson Sequoia C512 Echocardiography System C) Acuson Sequoia C512 Echocardiography System D) Acuson Sequoia 512 Ultrasound Accu-Chek Spirit Insulin Pump Siemens Medical Solutions USA. WS-03. 68211. 0021. 00-5964-017-51 B) 00599601451 6939-0-430 06F16-10 A) N/A B) N/A C) N/A 801763 802100 87000 0804CE394 to 0810CE295 >10 Numbers. This leakage is due to clogged vent holes creating over pressure in the bottle. Contact Manufacturer Syngo Imaging Update Package VB30A_HF26 Siemens AG 2009-05-25 2009-03-04 47067 Type III 10 014 063 1094. 1024. The primary boxes from these affected lots may not have the application instructions and caution statements printed on the inside flaps of the primary box.28. 1150. Inc. WR-02. A non functioning CCM could potentially cause the user to operate pumps using local pump controls. 8267697 C) 10038242 D) 10038241 04540492001. A) Artiste Syngo RT Therapist Assist B) Artiste Syngo RT Therapist A) Tilt/Elevating Seating System B) Tilt/Elevate/Recline Seating System Kinedx 4. 31. 08H358H. A size 43mm Austin Moore endoprosthesis curved stem was found packaged as a size 45mm stem. as otherwise indicated. Attachment will result in significant delay in treatment. Orthos CM Brackets are incorrectly labelled +9 degrees. but they have a torque of -9. 56454692. Device possesses non-conforming tip geometry. D513 (905-802) A) Symbia T/T2/T6/T16 B) Symbia S PSM with Validation Module Siemens Medical Solutions USA. 70196100. 55331. Also Trading As: Biomet Microfixation Roche Diagnostics GMBH Howmedica Osteonics Corporation 2009-05-25 2009-05-25 2009-05-25 2009-05-25 2009-01-08 45983 2009-04-02 47701 2009-05-01 48042 2009-04-22 48074 Type II Type II Type III Type III 620-040-600. requiring more force and potentially heating the bone surface during operation. 1026. 620-040-610 09-0142 3255379190 5570-T-020.Curved 43 mm i-STAT 1 Analyzer System-Instrument A) Zenith Renu AAA Converter B) Zenith Renu AAA Main Body C) Zenith AAA Main Body Bifurcated Stent Terumo Advanced Perfusion System 1 Advance Perfusion System 1 Galileo Echo Blood Bank Analyzer Zimmer Inc. 5570-T-040. Molecular Imaging Group Roche Diagnostics Ltd 2009-05-25 2009-03-04 47070 Type III 2009-05-25 2009-04-30 47890 Type II A) 08717733. Under certain circumstances. could result in mistreatment on another linear accelerator. Contact Manufacturer B) >10 Numbers. Inc. 851470 0810006605. Howmedica Osteonics . Cook.Derma Prene Ultra Surgical Glove Ansell Healthcare Products LLC 2009-05-25 2009-05-04 48229 Type II 851365. 93. Ormco Corporation Siemens Medical Solutions USA. it may result in additional phrases not populating as expected. WU-04. 70221300. CRB33250. It is however the same product in specifications and materials as JA-1101. may have evaporated in some vials. 98607GE5. PHH620227S C) PGY623319S. SC-3004. SVVI103 N/A A) >100 Lots. 64233. This update instruction provides improved fixation of the telescope support. Specifications for the intra-assay precision was not met independent of the Elecsys Digoxin Reagent or Precicontrol lot used. HUSC1588. 64362 894213H S/N'S 96090GE6. CRB33225. SS106.g. it was found the standard used to calibrate the assay. 2009-06-08 2009-03-03 48601 Type II 259416. . which is licensed for sale in Canada. Bottle caps are being too difficult to remove.5" highpressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the product. 2009-06-08 2009-02-17 48161 Type II A) HUSA1668. CRB23300. SS203. CRB13275. 802154-XX A) 48284050 B) 48284051 B03-4585-54 A) All Lot Numbers B) All Lot Numbers TP93037 A) MANTIS Rod Inserter B) MANTIS Rod Inserter Inner Shaft Advia 70 Testpoint Haemotology High Con Stryker Spine SAS 2009-06-08 2009-04-28 48210 Type II Siemens Healthcare Diagnostics Inc. 2009-06-08 2009-05-12 48471 Type III Acist Angiographic System-Manifold Kit Acist Medical Systems Inc. it was found the standard used to calibrate the assay. PGR625317S. SS303. During manufacturing. HUSD2647 11130-0000XX. SDR303. 64049. SVDD303. PGR625959S D) >10 Lots. HUSG0594 B) HUSH0816.V. GE Healthcare Roche Diagnostics GMBH 2009-06-08 2009-06-08 2009-06-08 2009-05-01 48472 2009-04-21 45984 2009-03-26 47413 Type II Type II Type III 13305-01 B79011MA A) 03530477190 B) 04917049190 A) VC10118P B) VC10118MR Identification of oxidization on some of the 25GA Trocar Blades packaged in the 25GA Total Plus paks which are part of the Alcon custom-pak procedure pack. or no output. PGW621053S. CRB18250. 64316. SDR306. 15612300 All Lot Numbers >100 Lots. SSR303. CRB33275. the split sphere may separate from the shaft.0 to 4. may have evaporated in some vials. In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stent. 2009-06-08 2009-05-18 48702 Type I >1000 Lots. model SU1101. CRB18350. SD303. Contact Manufacturer Sterilization efficacy for the current labelled methods cannot be confirmed. 64032. SSR303. HUSI0216. CRB18275. If evaporation occurs this will cause the standards to read erroneously.> 10. 262759 Quantikine IVD Human B2-Microglobulin R & D Systems. PGY623323S. Contact Manufacturer This is an update of performance and patient management recommendations for a subset of Sigma pacemakers previously recalled because of an increased rate of failure associated with interconnect wire separation caused by a particular cleaning solvent used in manufacturing. Inc. 261514. CRB18225. Contact Manufacturer B) PHH620224S. KSR706 F) KSR903 SD203.Cannula Alcon Laboratories Inc. is not licensed for sale in Canada. Bard Peripheral Vascular. PGY623355S. GS-3045-L. CRB08275. CRB08250. Human STFR Quantikine IVD Kit R & D Systems.40. Complaints that the Percent Eosinophils (EOS) is not recovering within the range specified for lot TP93037 of testpoint high control. CRB28250. loss of telemetry. CRB28350. a field safety notice has been issued to remind users to follow inspection and preparation steps. 11131-0000XX. Once deformed. 2009-06-08 2009-06-08 2009-05-14 48488 2009-04-27 48114 Type II Type I SU1101 4002. SS303. This can result in a situation where the alarm will not sound. 64069. 96091GE4. CRB13350. 64052. 98608GE3 A) N/A B) N/A When beams are renumbered. 03375790190 0788-300-012 CRB08225. CRB23250. SVVI103 B) KDR603 C) KDR703. premature battery depletion. 800441. SSR203. CRB23350. HUSC1533. CRB08350. CRB13300. SSR306. Respironics Inc.A) Pumps/Sequential Circulators B) BioComfort Arm Garments C) BioComfort Leg Garments Bio Compression Systems 2009-06-08 2009-05-11 48425 Type III A) SC-2004. 4003 209296 S/N: 3000033364 to 3000038740 Roche Diagnostics GMBH Stryker Communications Cordis Europa N. This may present clinically as loss of rate response. Some Vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast. were discontinued in August 2008. CRB13250. KDR706. SS106. Contact Manufacturer During manufacturing. The pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e. Custom-Pak Opthalmic Surgery Pak AW Volumeshare2 . KSR703. The supplier confirmed a value assignment error for this lot. leaving the broach or trial in the surgical site. the series could be incorrectly labelled in image view. Ready kits. CRB23225. CRB28225. CRB33350 N/A 15617400 & 15612200. GS-3045-S N/A 96-210-10001 8098027 A) N/A B) N/A C) N/A Medical devices sold in Canada by Bio Compression Systems are not licenced in accordance with the medical devices regulations. 64141. SDR203. 64137. Inc. The headrest has two pinch points that could result in hospital staff injury during the transportation of the headrest when it is detached from the table. Under certain conditions. SDR303. Siemens AG 2009-06-08 2009-06-08 2009-06-08 2009-05-05 48447 2009-05-08 48453 2009-02-25 48470 Type II Type II Type III Versions 4.Software Options A) Precicontrol Cardiac B) Precicontrol Cardiac II A) Vacora Vacuum Biopsy System B) Vacora Vacuum Biopsy System . Sigma Pacemaker System Medtronic Inc. KD706 E) KSR701. SC-3008 B) GS-3035-M. 2009-06-08 2009-04-14 47925 Type II Lifepak 9/9P Internal Paddles & Handles Physio-Control. 2009-06-08 2009-06-08 2009-06-08 2009-05-12 48228 2009-05-15 48498 2009-05-08 48561 Type III Type II Type III 03375781190. HUSD1075. Inc. CRB18300. Device may fracture at the threaded tip during use. contain gloves and antiseptic wipes that are not licensed in accordance with the medical devices regulations. KD703. part# 5550-003. Potential for precision issue with the Elecsys Cardiac and Cardiac II. 2009-06-08 2009-06-08 2009-02-10 48618 2009-05-18 48540 Type III Type I N/A A) SD203. CRB08300. CRB28300. CRB28275. 98606GE7. Contact Manufacturer F) >100 Lots. KDR721 D) KD701. Contact Manufacturer XX. SSR203. 64306. Contact Manufacturer E) >1000 Lots. GS-3045-M. Inc. SSR306. The manufacturer has received field reports of a bulge and leaks on the side of the 2.3. These Lifepak 9/9P internal defibrillation handles without discharge control & custom-mated paddles. If evaporation occurs this will cause the standards to read erroneously. SS203. XIO Radiation Treatment Planning System TM-400 Broach Handle Definition AS Computerized Medical Systems Zimmer Trabecular Metal Technology. it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. GS-3035-S C) GS-3045-H. CRB33300.0 All Lots 64238. SD303. Inc. A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. which could lead to under-treatment of a tumour. CRB13225. 2009-06-08 2009-05-13 48480 Type II BT2000 3168H Insufflation Tubing With Filter SmartMonitor 2 Infant Apnea Monitor Updated recall # 48114 previously posted on 200905-11. connector). Preciset TDM I / Preciset TDM II Vertier Table Headrest Attachment Cypher Select + Sirolimus-Eluting Stent Medovations Inc. The device. battery. The stainless steel split sphere in the Mantis Rod Inserter Shaft has the potential to become deformed when subjected to high force. CRB23275. 2009-06-08 2009-03-04 48674 Type II N/A 260980 Ready Kit A) Sigma Pacemaker System B) Kappa 600 KDR Series Pacemakers C) Kappa 700 KDR Series Pacemakers D) Kappa 700 KD Series Pacemakers E) Kappa 700 KSR Series Pacemakers F) Kappa 900 KSR Series Pacemakers Cardiac Science Corporation Medtronic Inc. SVDD303. HUSI1063. SDR306. SDR203. 2009-06-22 2009-05-28 48864 Type II A) 680 2865 B) 680 2863 A) 36000116.. Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007 and incorrect/elevated results. 19500-22 H74916320201. 21. 2843270. H74919815520 B) H749198155010 B) 19815-501 C) 16320-72. This can result in deletion of allergy information. which could injure patient or user. H74916320781. 045100705V300. H74919815920 92. Table locks may not actuate. N/A PSS-5F-4MT. This crack is located on the bottom of the dish along the stacking ring. 2009-06-22 2009-06-22 2009-06-22 2009-05-15 48595 2009-05-19 48605 2009-05-06 48608 Type II Type II Type III A) 70834 B) ALLURA XPER FD10/10 7C15-01 L2SUBX A) N/A B) N/A > 10 Numbers.7mm Cortical Screw Self-Tapping package could potentially hold the 4. Abbott Laboratories Diagnostic Division Siemens Healthcare Diagnostics Inc.08. This configuration could result in delamination of the inner tyvek seal as the package is opened. Contact Manufactuer > 10 Numbers. The sidearm tubing may detach from the sheath during use.. 2952392. The previous results retrieved from the specimen management database. Product out of specs with thread outer diameters. 56000337 Prelude Short Sheath Introducer Merit Medical Systems Inc. H74919500720. 19815. A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. PSS-6F4MT. The stem threads on some units in this lot may be nonconforming. Contact Manufactuer > 10 Numbers. 20148714.01. 2009-06-22 2009-05-29 48935 Type II Disposable Endoscopic Surgery Blades Steris CMAX Surgical Table Hand Control Smith & Nephew. 73. H74919500780. PSS-7F-4MT. the internal components of the hand control and/or the table control board may become damaged. H74919500390. 9100 MTS110003 A) N/A B) N/A C) N/A D) N/A E) N/A N/A A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots have been identified as having a microscopic crack on the lateral side of the condyle in the posterior chamfer region. Dishes containing a small crack. 061400907V3. VSU0802003. 20153849. 2843268 20148707. 16320-18. 19500. Contact Manufactuer 07160407V3. . H74919500210. 254 A) Vitros 3600 Immunodiagnostic Software B) Vitros 5600 Integrated System Software Ortho-Clinical Diagnostics Inc. which may affect the performance of the Immulite 2000 and Immulite 2500 assays. H) 19815-583 H74919815410 G) H749198155540 H) H749198155830 960005 2843263. 061406905V300 > 10 Numbers. 043600401V200.06. Dickinson And Company Getinge Disinfection AB Mediland Enterprise Corporation 2009-06-22 2009-06-22 2009-06-22 2009-02-17 47220 2009-04-24 48035 2009-04-17 48613 Type III Type II Type III A) model/catalog # 4235 B) model/catalog # 4250 C) model/catalog # 4220 D) model/catalog # 4245 E) model/catalog # 1110 IM-B02V8. H74916320211. Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hosing causing loss of control of the table surface.A) Multidiagnost Eleva-Flat Detector B) Allura XPER FD10/10-Main Unit Architect Reaction Vessel Chemiluminescent Substrate Philips Medical Systems Nederland B. 19500-71. H74919815720. 19500-78. 56000124. If both screws back out completely. 19500-74. 20153865. 19500-29. it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area. 7210499 N/A A) Picis OR Manager B) Picis Preop Manager C) Picis Anesthesia Manager D) Picis PACU Manager E) Picis Critical Care Manager Instrument Manager Picis Inc. This could cause a loss of hand functionality. 041600323V200. Contact Manufactuer The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in Australia. PSS-8F-4MT VSU0802002. Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. It occurred within a hospital environment. Dyonics 25 Tube Set Kits Compax 40E Table Smith & Nephew. software will allow patient allergy and precaution data to be overwritten with automatic updates from the hospital information system (HIS). 2009-06-22 2009-06-22 2009-06-22 2009-05-27 48913 2009-06-01 48914 2009-06-01 48988 Type II Type II Type II 00-9982-015-18 00-4827-024-01 00-6428-032-02 60698102 60886890 61007046 The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier. F) 16320-141. H74919500770. 36000130 B) 56000193. 19500-02. 19815-41 E) H749198154460 G) 19815-554 F) H749163201411. These substrate lots may introduce a shift in both quality control and patient results. There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging.0mm cancellous screw partially threaded (part number 00-4840-022-01). preventing the compression nut from engaging on the stem. 19500-20. 043600402V200. Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. 20154971 AC001 TO AC0221 The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet. PSS-6F-4-018MT. If not properly configured. H74919500730. 2845530. Inc.09 N/A 9027.7mm Cortical Screw Self-Tapping Alumina Ceramic Femoral Head Zimmer Inc. 2009-06-22 2009-04-08 48937 Type II Data Innovations 2009-06-22 2009-05-11 48997 Type II BD Falcon 100X20 mm Tissue Culture Washer Disinfectors With Transformer ASC 2000 Ambulatory Surgical Table Becton. 19815H74919815710. VSU0802001. H74919815730.00. Inc. 2) bidirectional (longitudinal and lateral) axes. 7211006 N/A ZMR Hip System-Stems 2. IM-B02V8. 56000336. complicating removal of the implant from the package while maintaining sterility.V.A) H74916320021. Complaints received regarding substrate l2subx lots 253 and 254. 56000136. which may be used by rules. which may result in the leakage of cell culture media during incubation.07. PSS-5F-4-038MT. 2009-06-22 2009-04-20 48882 Type II VS Ventilator A) Wiseguide Guide Catheter Femoral B) Wiseguide Guide Catheter Allright C) Wiseguide Guide Catheter Voda D) Wiseguide Guide Catheter Amplatz E) Wiseguide Guide Catheter Bypass F) Wiseguide Guide Catheter Multipurpose G) Wiseguide Guide Catheter Radial H) Wiseguide Guide Catheter Kimny Resmed Paris Medi-Tech Boston Scientific Corporation 2009-06-22 2009-06-22 2009-06-01 48885 2009-03-13 47359 Type III Type III PSS-5F-4-018MT. when the display/report screen is configured by the operator. Contact Manufactuer 253. may not be the most recent previous version. Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. 19500-73. If this failure occurs. > 10 Numbers. 2852394. 7206011. Endoscopy Division Steris Corporation 2009-06-22 2009-06-22 2009-05-08 48408 2009-05-22 48912 Type II Type III 7206010. 2844381. Zimmer Inc. Endoscopy Division GE Healthcare 2009-06-22 2009-06-22 2009-05-29 48968 2009-02-18 45258 Type II Type II 7211005. 19815-71. 19815-74 D) 16320-17. The 2. N/A VSU0711510 A) 16320-02. 2842528. It is possible that screws without the loctite can work loose and the clip can become separated from the hand control. 56000298. E) 19815-446 H74919500220. H74919500020. 16320-78. causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes. IMB02V8. 16320-20. H74919500740. an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System. 2844799. PFC Sigma CR Non-Porous Left Femoral Depuy Orthpaedics. 72. Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. 19500-77. Inc. H74916320181. Investigation has found that under a very specific set of circumstances. 19815-72.C) H74916320721. H74919500710. 19500-39. Microscopic cracks have the potential to affect the performance of the implant. 2869123. 19500-21. H74919500290. IM-B02V8. 16320. Zimmer Inc.H74919815740 D) H74916320171. 2845534. 0T B) ACHIEVA 1. It complies with European pharmacopeia instead.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus. This problem affects revision C and D of the software. it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. The positive bias of approximately 0. HIT > 10 Numbers. Product made with incorrect buckle. Contact Manufacturer B) > 10. Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. CIC Pro Clinical Information Center GE Healthcare 2009-06-22 2009-02-19 46853 Type II CIC-XXXX-XXXXX-XXXXX* S/N'S SDY09020430GA & SDY09030443GA Hinged Knee Brace Intellivue MP70 Patient Monitor System Trainer's Choice Philips Medizin Systeme Boeblingen GMBH 2009-06-22 2009-06-22 2009-01-07 48389 2009-05-22 48839 Type III Type II 101 M8007A 8-31313-00003-2. Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7. 31036. In rare circumstances. 06F03-02 A) All Lots B) All Lots C) All Lots D) All Lots A) All Lots B) All Lots P08321C HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inserts state.5T MRI System-Main Unit A) Avalon Fetal Monitor FM30-Main Unit B) Avalon Fetal Monitor FM20-Main Unit Philips Medical Systems Nederland B. which are: USA paper style and 3 cm/min paper speed. 2009-06-22 2009-05-08 49074 Type II 8. S27947.01.15.1_M4_0818A version of software can result in images being flipped under very limited and specific conditions. Contact Manufacturer .0 to v4.9999 on the extended brilliance workspace. e. The outer box information is correct as well as the barcode information on the plate frames and microplate strips.1. SYS1000-L3PHA B) SYS1000-L3DPHA. ARENASPX-HR A) 4R9734 B) 4R9734 06F03-01. Abbott Point Of Care Inc. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred.0. Product integrity and effectiveness was not affected. The product is correctly identified. If this change remains undetected by the user.1 software may fail and result in potential loss of monitoring and inability to power up after powering down of CIC Pro. 722044* F) ALLURA XPER FD10 G) N/A H) N/A I) N/A V100-QBAA-CXAA-XX MUSESW7-XXXXXXXX A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A > 10 Numbers. 36103.0.1 Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5. A user/clinician changes. SYS1000-L3PA. Biotest Medical Diagnostics GMBH 2009-06-22 2009-06-22 2009-06-22 2009-05-11 47837 2009-05-29 48899 2009-04-03 49138 Type II Type III Type III 2294302. 2009-06-22 2009-05-12 49048 Type II GE Medical Systems Information Technologies GE Healthcare 2009-06-22 2009-06-22 2009-02-09 46236 2009-03-04 46833 Type II Type II A) 722041*.6. SYS1000-L3PHDP C) ARENASPP-DH. Inc. treatment to incorrect volume could result.5 R/min Health Canada requirement. LLC Siemens Healthcare Diagnostics Inc.11.1.5. the right/left annotations will be reversed on views that were created with a short curve. The potential failure can lead to a radiation exposure rate in excess of the 11. A) Achieva 3.Tina C) Arena SPP Hemodialysis Delivery System D) Arena SPX Hemodialysis Delivery System Baxter Healthcare Corporation 2009-07-06 2009-04-09 47924 Type III A) Isolex 300I Magnetic Cell Separator B) Isolex 300 Magnetic Cell Separator Stat G3+ Cartridges Baxter Healthcare Corporation 2009-07-06 2009-05-04 48344 Type II A) SYS1000-L3DPHA. edits or acknowledges the A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked successfully archived even though the content is saved sporadically with defective pixel or header data. 34170. however the product description immediately below is incorrectly stated. 8-3131300002-5 N/A Sireskop SX/SD Siemens AG 2009-06-22 2009-02-11 47071 Type III 10093754. Evidence of mold was found on the leather pieces on the outside of the braces. 7910010 1. 21087. 8. An error in the coding of the 11. Philips Medizin Systeme Boeblingen GMBH 2009-06-22 2009-06-22 2009-06-09 49149 2009-06-09 49150 Type II Type II A) ACHIEVA 3. 2009-07-06 2009-07-06 2009-05-15 49192 2009-06-10 49196 Type II Type III N/A A) 07566733 B) 07566733 N/A A) > 10.System Posey Buckle Erytype S RH Donor Plates GE Healthcare J T Posey Co. 1.A) Integris V5000/BV5000 B) Integris H5000F Cardiology Imaging System C) Integris H5000C Cardiology Imaging System D) Integris BH5000 Cardiology Imaging System E) Integris Allura F) Allura XPER FD10 G) Integris H1000 H) Integris H3000 I) Integris V3000 Carescape V100 Muse Cardiology Information System Philips Medical Systems Nederland B.2.Aurora B) System 1000 Dialsate Delivery System . 2009-07-06 2009-05-12 48497 Type II LCT-1000 Therapy Laser A) Advia Centaur B) Advia Centaur XP Litecure. The problem occurs when the powerup/boot sequence of the fetal monitor is interrupted. 7.5T Signa Infinity MR Excite . Contact Manufactuer 235018. 21107. If scheduled orders are documented and edited prior to the orders' original schedule time. Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch seals.. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard. M3000CB N/A 806190100 Aria Radiation Oncology Varian Medical Systems. the settings for paper scale type and recorder speed may revert back to the factory default settings. If a cartridge or suboptimal pouch seal is run. The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet. However. An order or intervention is entered as a scheduled administration and 2. 2009-06-22 2009-06-10 49151 Type II 455011202691 N/A A) System 1000 Dialsate Delivery System . if the following conditions occur: 1.V. 7. This issue may pose a risk for patients or users. Contact Manufactuer The alarm and pulse volume indicators are inverted on the label of french language units. 7. 235036. it will only occur if the grid switch fails during fluoroscopy examinations using high KV values. Manufacturer has determined that specific lots have shown decreased specificity for negative populations. One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet. S27957 7839010. 8-31313-00004-9. may deliver between 40 & 60 ml/min. ARENASPP-H D) ARENASPX-BDH. 41021 > 10 Numbers. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption. SYS1000-L3PA. A clinician charts the pending order earlier than scheduled and 3. 21040. contrary to operator and service manuals. If the change to the plan had been to parameters other than dose per fraction.3 index units and specimens with 0. 3111668 21005.07.0T MRI System-Main Unit B) Achieva 1.5 to 0. SYS1000-L3PHA. 8. Contact Manufactuer A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected.0.0. The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device. potentially leading to serious injury.1 & 7.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor system) can create a second instance of the same order marked as pending.5T A) M2703A B) M2702A A) N/A B) N/A A) DE53001002 Through DE53107383 B) DE53001002 Through DE53107383 Brilliance 6/10/16 Slice CT-SFRTWR Dent Philips Medical Systems (Cleveland). Inc. potential for failure. Carevue Chart Release C.g. An Arena instrument set to deliver 50 ml/min.1. SYS1000-L3P. 722042* B) 722017 C) 722016 D) 722021 E) 722043*. 31 11 676. SYS1000-L3PH. When images are saved or filmed that contain the curved multi_planar reformation section (CMPRS) while using the dental application v4. 21110. there is a possibility that the performance of the cartridge assays may be impacted. Contact Manufactuer > 10 Numbers.V. SYS1000-L3P. 507311. For some customers the results may be out of range and could result in a quality assurance investigation at the customer's site. There are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mount and fall. 60203906. 60186251. it was determined that the outer blister did not meet the required minimum seal width. 005880-005-00. which could puncture or rupture the skin of the patient. (Note: the inner blister seal was not affected). Reduced ultrasound output may affect the progress of patient fracture healing. 516518 89261CB. or BNMAZ using ImmunoCAP Allergen E1. VRC126. BNMAZ B) BNMAX. 490656.Definium 5000 Digital Radiographic System GE Healthcare 2009-07-06 2009-06-11 47773 Type II 5220493-2 GEHC00070 & GEHC00096 Chloride Membrane on ABL 700 & 800 Flex Radiometer Medical APS 2009-07-06 2009-06-05 48585 Type III 942-061 177 Delfia Xpress PAPP-A Kit Sur-Catch No Tip Nitinol Stone Basket Wallac OY Gyrus Acmi. VRC125.8% Resolve Panel B Reagent RBC C) 0. 00-5880-014-02. 506860. Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to being shipped from the factory. 41600-5. 0682-001-111 All Lots Digital Radiography Imaging System Toshiba Medical Systems Corporation 2009-07-20 2009-06-12 49202 Type II TFD-3000A1/WV N/A A) 0. Contact Manufacturer A) S3 Med/Surg Bed Fowler B) Secure II Med/Surg Bed Fowler Dall Miles Trochanter Cable Grip System Stryker Medical 2009-07-20 2009-06-11 49199 Type II A) 302S3-000-000 B) 3002-000-000 6704-0-210 A) All lots B) All lots Serial # 29233201 Howmedica Osteonics . the target image cannot be displayed or output to an external device after the system is simultaneously operated from the control room and the examination room in the Radrex-i system. 2009-07-06 2009-05-18 49146 Type II I3000. VRC127 Serial # 11040079567. VRA127. 60160461. with a variable error magnitude. it has the potential to cause a leak of contrast material. Cell-Dyn 1700cs. VRB124. In rare cases. 2009-07-20 2009-06-11 49448 Type III A) 6902317 B) 6902318 C) 6902319 Quinton QStress TM55 Stress Treadmill Exogen Bone Healing System Cardiac Science Corporation Smith & Nephew. may not be the most recent previous result. Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimator not in Park mode during treatment. OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. This action is being conducted because these components are labelled with a ten year expiry period when in fact these components expire five years after manufacture. Inc. During post-sterilization inspection of the outer blister of the affected lots. Inc. on a Cell-Dyn 1700. resulting in "diluent empty" faults. 41600-6 01-006-41600. after first exposure terminates. It is possible for the identified devices to emit smoke from the blower box assembly. 2009-07-06 2009-06-08 49105 Type II A) Immunocap 250 Specific IGE Control B) Immunocap 100 Specific IGE Control Phadia AB 2009-07-06 2009-03-29 49233 Type III A) 00-5880-014-01. customers reported breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to use.8% Resolve Panel A Reagent RBC B) 0. 01-044-41600. 60141825 B) 60195329. VRA126. VRB125. 2009-07-06 2009-07-06 2009-06-18 49308 2009-06-19 49361 Type III Type III IM-B02 VX. 60206499. Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results may be falsely elevated or depressed. Received a report of damage to the distal shaft of the catheter. This may cause a critical under-dosage of the target region. BNMAY. 503140. 91666DB A) Nexgen Rotating Hinge Knee-Femoral Component B) Nexgen Rotating Hinge Knee-Tibial Component Zimmer Inc. A leak has the potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use.no 10-949-01) containing vial lot BNMAX. 03H57-03 B) 07H77-01 A) N/A B) N/A Powersail Coronary Dilation Catheter Abbott Vascular 2009-07-06 2009-06-18 49279 Type II 1005726-08 7112051 Instrument Manager Dimension Vista System-Urea Nitrogen Assay Data Innovations Siemens Healthcare Diagnostics Inc. Previous results retrieved from the specimen management database. VRA125. 00-5880-015-02. Due to an error. 60191094 A) BNMAX. E41600-3/30793 E-Cylinder Canister Holder Stryker Communications 2009-07-20 2009-06-08 49172 Type II 0682-000-449. (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art. subsequent exposures fail to terminate because functionality of ion chamber ramp comparator with low reference voltage is not reliable. Inc. 2009-07-20 2009-07-20 2009-03-30 49032 2009-06-10 49177 Type II Type II N/A 71034101 A) VRA124. BNMAY. surgeon or attending nurse and lead to increased risk of infection. VRB126. Nobel Biocare AB 2009-07-06 2009-07-06 2009-03-31 48593 2009-05-21 48621 Type II Type II N/A N/A All Lots 687218 Handle body may crack or fracture.8% Resolve Panel C Reagent RBC Ortho-Clinical Diagnostics Inc. BNMAZ When configured for AEC. 60170823. 005880-015-01. Inc. Patients who have already been treated are not affected by this action and this action does not affect any other part number or lot number of the Powersail product line. lot no. A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 00-5880-004-00. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head. Use of the current available version of the 10ml diluent syringe. 687218) was incorrectly packaged with the larger size 06x9mm. 11040079568 > 10 Numbers.Stryker Ireland 2009-07-20 2009-06-15 49278 Type II . Phadia AB. part number (p/n) 9212368 (without spacer). leading to the possibility of an increased false positive rate in screening programs. The cause of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch assembly. BNMAY. Manufacturer updates information on target range values for one of seven ranges stated in the directions for use.XX K1021 N/A 09061AA M3 Micro-MLC For Varian With MLC Brainlab AG 2009-07-06 2009-03-19 47235 Type II 41600-3. There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. 60163665. Product is a control sample used by laboratory for internal quality assurance. A new range is established for ImmunoCAP Allergen E1. 60137094. Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride electrode to be very low and the analyzer rejects calibration. Dual Offset Broach Handle Left and Right Impression Coping Closed Tray Regular Platform 05x9mm Flexicair Biomet. The older version of the device has a design defect which allows for a fatigue related failure. which may be used by rules. The Internal Varian F-Collimator could interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. There is a decrease in the measurement of PAPP-A levels compared to previous lots. Hill-Rom Manufacturing. some product was shipped out with a new polyamide sleeve material before the qualifying process was completed. VRA128 B) VRB123. 2009-07-06 2009-07-06 2009-05-21 48607 2009-06-04 49030 Type II Type II 6003-0020 5711222 490042. 60144695. 60173203. 60180540. Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the label. 60230599. 03H57-01. While the issue should be detected during the preparation of the product. VRB127 C) VRC123. M4000 N/A A) Cell-Dyn 1700 Analyzer/1700CS Analyzer B) Cell-Dyn 1800 Analyzer Abbott Laboratories Diagnostic Division 2009-07-06 2009-06-12 49223 Type III A) 03H53-01. 00-5880-006-00 A) 10-9449-01 B) 10-9449-01 A) 60147327. 60174823. 34235. Because of this. 91665DB. 41600-052-99. called a transducer. Hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms. 89262CB. 00-5880016-01 B) 00-5880-002-00. or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initialization of the analyzer. In some of those complaints. N/A The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create separate and distinct surgical protocols. causing the circuit breaker for the specific electrical outlet to trip. 2009. resulting in those images being displayed erroneously on external DICOM device.0. WM-WP1. A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg. Inc.0.2 D) Amplilink Software V 3. EXPAbbott has observed an increase in complaints for the following error codes when using ARCHITECT Total β-hCG Reagent with specified lots: -1109 "assay (X) number (Y) calibration failure. An additional 5 potential cases outside of Canada and the USA are under investigation. WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened. Architect I System-Total B-HCG Reagent Abbott Ireland Diagnostics Division 2009-07-20 2009-06-30 49556 Type III 7K78-20. c9011. It only displays the last batch of events acquired.1005 "result cannot be calculated.7000. 2009 was affected. c9015. (L)08CW16248 The engraving on the plastic cap does not match the outer label indications for size. Contact Manufacturer > 10 Numbers. As such.1. The engraved numbers on the impactor cap do not agree with this information and are erroneous. The magnets were made such that the metal case surrounding the magnet is not properly welded. 2009-08-03 2009-08-03 2009-08-03 2009-08-03 2009-06-01 48484 2009-06-15 49293 2009-06-26 49463 2009-06-22 49490 Type III Type II Type III Type II Default configuration may have been modified so that rejected images are included in the retrieved exam. Cable Unit Smith & Nephew. Genesis II Femorals Coonrad/Morrey Total Elbow System Laparo-Thoraco Telescopes.Olympus Mobile Workstation. leading to headpiece retention issues.x. The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter. 1) In versions 1.2. While running the AmpliLink software. 03146707119.8000. WM-DP1. Olympus Winter & IBE GMBH 2009-07-20 2009-07-20 2009-07-20 2009-06-10 49201 2009-06-09 49362 2009-06-25 49518 Type II Type II Type III 71420026 08HM17084 32-8105-038-00 61249897. Under certain circumstances. NX SOFTWARE 3. 7K78-25 BHR Acetabular Cups Smith & Nephew Orthopaedics Ltd. NX2008 Or NX. 10122 . A50023A. 4308. LLC 2009-07-20 2009-06-12 49409 Type II CI 1400-01. Siemens Medical Solutions USA. A limited number of complaints have been received regarding the Carendo related to skin pinching.7000. AB is aware of 14 defective magnets.2009 have tested positive for a pseudomonas type species of bacteria. AB reports that devices manufactured between May 27 and June 30 of 2005 may have a magnet laser welding defect. The power supply have short circuited at the electrical outlet upon initial use of the power supply. Contact Manufacturer BD MultiSET Software V. EXP 17 DEC. > 10 Numbers.1 and 1. The BHR Acetabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. c9013. Trending has shown a number of events relating to what has been generally described as clip detachments.0.V. A patient implanted with an unwelded magnet could experience a decrease in the strength of the magnet over time. 2009-07-20 2009-06-16 49339 Type III MAJ-174. Due to a production failure of the manufacturing partner.1. 2 of the replacements were for devices sold in Canada. final RLU read is outside the specification of the lowest calibrator". A multi-sipping issue was found in BD MultiSET Software Version 3. 61249899 A50001A.0. there are possibilities (under certain circumstances) that an assay is being performed with the test file parameters of another assay. CI-1400-01 and CI-1400-02h). MH-787 Serial Numbers Less Than 2810808 Carendo Multipurpose Hygiene Chair Arjo Hospital Equipment AB 2009-07-20 2009-06-16 49446 Type II BIB2003-01 > 10 Numbers. Devices manufactured outside the above time frame were not affected. In 7 cases the unwelded magnet resulted in surgery and replacement of the magnet.1 Becton. one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.2009 and March 26th. 643437. Contact Manufacturer A) Central Venous Catheterization Set B) Central Venous Catheter Accu-Chek Softclix Lancets Kuschall K-Junior Manual Wheelchair Stromatolyser-IM NX 8000 With V.3. Kodiak Power Supply Acuson P50 Diagnostic Ultrsound System Breg. c9017 N/A Roche Diagnostics GMBH Kuschall AG Sysmex Reagents America AGFA Healthcare N. NX SOFTWARE 2. Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3. A50021A.8000 N/A 10041762 A) > 10 Numbers. 3908.1. 2009-07-20 2009-06-30 49557 Type II 74120152 74908JN00. a problem of image mis-up can occur on the inroom NX system. c9016. Trident Acetabular Surgical Protocol Howmedica Osteonics Corporation 2009-07-20 2009-06-15 49269 Type II N/A Removable Magnet Hires 90K Advanced Bionics. CS-15123-E B) MC-12123. Transformer Keymed (Medical & Industrial Equipment) Ltd. The magnet is designed to be surgically removable if the Cochlear Implant patient needs to undergo an MRI.Hardware Roche Diagnostics Ltd.0. the distance between the coverglass of the light guide cable and the ledge does not meet specifications. 2) In non-cardiac application. Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Implant (model no. Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched on.2. Inc. Smith & Nephew has received complaints of lugs missing from the femorals. can be an error in estimation of velocity when using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace. 2009-07-20 2009-06-16 48878 Type II GE Healthcare Integrated IT Solutions 2009-08-03 2009-05-26 47838 Type II A) CAT #04807197001 B) CAT #04855094001 C) CAT# 04862392001 D) CAT #05093236001 E) CAT# 05201357001 K2033LP A) All Lots B) All Lots C) All Lots D) All Lots E) All Lots > 100 Numbers.2 Build 0502 C) Amplilink Software V 3. 2009-08-03 2009-05-11 48476 Type II A) CS-12123-E. c9014. 74908JN01. CI-1400-02H N/A A) Amplilink Software V 3. Based on random sampling AB has determined the weld failure occurred at a rate of 1 in 126 devices.0. 2009-08-03 2009-08-03 2009-06-18 49511 2009-06-19 49589 Type II Type III 3508.8000 Arrow International. Contact Manufacturer 806135534 c0910. The software is not adjusting its acquisition criteria for some samples. the needle guide feature was to be disabled for all transducers but actually activated for 1215 transducer.1 E) Amplilink Software V 3. There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in blood glucose meter kits.1 B) Amplilink Software V 3. If the Carendo is not used in compliance with the device instructions for use. user is unaware of miscalculations. Zimmer Inc. Dickinson And Company 2009-07-20 2009-06-24 49459 Type III 643347. the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay. 03583031002 K-Junior SIM-220A NX SOFTWARE 2. A50003A. MC-15123 03146693119. ratio too small for CAL B/CAL A" and /or . The missing lugs are apparent to the user upon opening of the inner sterile tray. NX SOFTWARE 3.2 Centricity PACS Workstation . CI-1400-01. Inc. Production between January 2009 and May 28. 4808 10120. Contact Manufacturer WA50003L Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch. Inc. 644459 N/A The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-NP1. Contact Manufacturer B) > 10 Numbers. after opening and closing a study on a CMS system while a study is still open on an in-room NX system.1. 2009-08-03 2009-08-03 2009-06-25 49594 2009-06-19 49618 Type II Type II N/A 3007301. 2009-08-03 2009-07-01 49781 Type II A) 303434 B) P2377 C) P2600 D) P3889 A) BHS 301 B) BHS 202 C) BHS 102 D) BHS 130 E) BHS 301 SCULPTOR F) BHS 302 G) BHS 135 H) BHS 140 A) Posey Soft Belt With Crotch Strap B) Posey Breezeline Pelvic Holder Synchron Rheumatoid Factor (RF) Reagent J. MMT-399 > 10 Numbers. areas of modified material properties may result. CAXJ910A. CAXJ827A. Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communication and patient data. If the vent does not work properly.Stryker Ireland 2009-08-03 2009-07-03 49713 Type II Paradigm Quick-Set Infusion Sets Unomedical A/S 2009-08-03 2009-07-07 49737 Type I A) T80998AA. Walter Lorenz Surgical.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips CT system for P3T cardiac protocol.Transmitter Hispeed FXi. T. où est inséré le réservoir. the pre-diagnostic protocol must include a transit bolus. LXi System GE Healthcare GE Healthcare 2009-08-03 2009-08-03 2009-02-20 45337 2009-01-13 45604 Type II Type III APROCH-XX-XXX-XXX-X B7520AZ.0 and 104. CAXJ834J. 120508-0116. T55344DA. Inc. T80998AC. 29110402. This affects PCR Eleva system connected to a RIS. parameters & alarming and inconsistent time values. Specific lots of prepared plated media may be experiencing random fungal contamination. M804502. 28719201.A. 2009-08-03 2009-06-30 49558 Type III Body Health S. did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S. Calibration failures occur at 12 months.0 Compression l Plate. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material. CAXJ834C. The third party supplier. 120508-0107. A) Cancellous Bone Screws B) Gap Plate Screw Howmedica Osteonics Corporation 2009-08-03 2009-07-03 49712 Type II A) N/A B) N/A A) > 10 Numbers. Contact Manufacturer B) > 10 Numbers. loss of waveforms. Possibility that choice of patient will be changed when using filtered work lists. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stellant CT Injection system. il peut en résulter une administration excessive ou insuffisante d’insuline. 6829008. Inc. Si la bouche d’aération fait défaut. / Environ 2 % des dispositifs de perfusion des lots concernés (lots commençant par 8) ne permettent probablement pas à la pompe à insuline de s’aérer convenablement. 28932601 D) 29389202 E) CAXJ826A. for material used to manufacture the Restoration Modular Components. T80554AA B) > 10 Numbers. 287223-1 C) 287232-1 D) 287173-1 A) 131108-0471. 6818808 N/A Apexpro Telemetry System . 28749101. Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro. 6 Hole Left Philips Medical Systems (Cleveland). par rapport à l’air ambiant. B7530AZ S/N RT908139180GA > 10 Numbers. for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw. 120508-0113. Normally problem detected because the "active" name of patient is displayed. As a precaution and due to the potential impact on the mechanical properties of the affected products. 6 Holes Left package may have contained a similar part 62-5441 2. As such. X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Beckman Coulter Inc. L’aération est nécessaire pour pressuriser le compartiment de la seringue. 3014849 CO081010 N/A The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely detach. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452. Hip Broach Body/Bolt E) Restoration Modular Conical Distal Stem F) Restoration Modular Conical Bowed Stem Howmedica Osteonics . 120508-0112. 120508-0114. 1. Inc. which may affect the intended use of the product. Stryker is recalling all products manufactured from material supplied by this supplier. MMT-397. Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur. the potential for variability of the material used in manufacturing the affected lots could compromise the strength. A defect in SW version 103. A) Restoration Modular Calcar Bodies B) Restoration Modular Hip Body/Bolt STD C) Restoration Hip Body/Bolt D) Restoration Mod. 080408-0094. . M804502. 287425-1 B) 286811-1.Icelock expulsion valve 551 Stellant CT Dual Injector Systems P3T OSSUR HF Medrad Inc. Contact Manufacturer CIC Pro Clinical Information Center GE Healthcare 2009-08-03 2009-06-05 46547 Type II CIC-XXXX-XXXXX-XXXXX* > 100 Numbers. 28914301. Label clarification. Contact Manufacturer Stryker has become aware that the third party supplier. it may fail calibration with the condition of "math error" on the calibration report. Concerns of increased patient exposure due to leakage of radiation. 120508-0106 D) 201207-0137 E) 181108-0179 F) 050208-0087 G) 140108-0238 H) 070607-0021 A) N/A B) N/A M802452. 131108-0474 B) 160708-0134. The possibility of part number 62-5442 2. T80550AA. Contact Manufacturer A) Brilliance 40/64 Slice CT System B) Gemini TF PET/CT System 2. Part Of GE Healthcare Philips Medical Systems DMC GMBH 2009-08-03 2009-08-03 2009-05-27 49796 2009-02-23 46769 Type III Type II N/A MCR1511 Lot # 6828908. Also Trading As: Biomet Microfixation 2009-08-03 2009-08-03 2009-07-16 46654 2009-06-29 49529 Type II Type III A) 4550 110 02031 B) 4550 110 09021 62-5442 A) N/A B) N/A 24180 A) Sabouraud Dextrose Agar B) Middlebrook 7H11 Agar C) TSA + 5% Sheep Blood (BA) D) Nitrient Agar A) BHS 301 B) BHS 202 C) BHS 102 D) BHS 130 E) BHS 301 SCULPTOR F) BHS 302 G) BHS 135 H) BHS 140 PML Microbiologicals. M807345. 3010432.0 Compression L Plate. T81105BA. As the Synchron RF Rreagent ages. MMT-398. Contact Manufacturer C) 29054602. which may necessitate a re-screening. Posey Co. has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. this could result in too much or too little insulin being delivered. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. 131108-0472. 2009-08-03 2009-08-03 2009-07-08 49840 2009-07-08 49912 Type II Type II A) 4125C B) 4411 475136 A) 286801-1. CAXJA29D F) CAXJ951A MMT-396. 090408-0090 C) 080408-0082. CAXJ834A. Contact Manufacturer A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A '903' Newborn Screening Cards PCR AC-500/PCR AC-5000 Basic System Whatman. 2.0 Compression l Plate Right instead of the 62-5442 part. M808329 Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the insulin pump to vent properly. T80551AA. 29054902. 120508-0115. were not licensed in accordance with the medical devices regulations. There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID. M807345 and M808329. 28932002.A. 001K to 149K inclusive When using CT Perfusion 4 algorithm on data with longer time sampling intervals. 2009-08-17 2009-05-11 48114 Type I 4002. A site reported that their End-to-End targeting accuracy was out of specification. It can exceed the upper quality control limit of 0. Proper validation was not performed on using the headset in an inverted (upside down) manner as described in the noted system's operators manual. CLINAC > 10 Numbers. 8420-107-125. Reduced battery performance (estimated at 2. under certain conditions. The negative control shows an elevated signal. Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma. Contact Manufacturer IX H27. 878608. 2009-08-03 2009-05-29 50003 Type II A) 870139. 8420-107-135 27600 C185 Smartmonitor 2 With PCMCIA Respironics Inc. 2009-08-03 2009-06-30 49853 Type II Fogarty Occlusion Catheter Baxter Healthcare Corporation. For lot KNTK. For affected pumps. Inc. 874182. 2009-08-03 2009-07-14 49947 Type II 2170-3002A N/A Corin Limited 2009-08-17 2009-07-20 49985 Type II 514. the minimum time frame of 90 days between ERI and end of service (EOS) may also be reduced. 866060. 882391. Inc. initiates notice of correction for Triage TOX Drug Screen Kit. Contact Manufacturer PWH0201 Instatrak 3500 System MIS Diamond Burs Cyberknife Robotic Radiosurgery System GE OEC Medical Systems Inc. IT35214P.CT Perfusion 4 GE Healthcare 2009-08-03 2009-06-16 48164 Type II 5189396 > 10 Numbers. contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. R332037R. Edwards Critical-Care Division Ormco Corporation Medtronic Inc. The unit package seals on the BD 60 ml Luer lock syringes. The Broselow/Hinkle Intraosseus Module. 7700YIO2 62080822F A) 245F to 366F inclusive. 7730IALS. 6L45-40 B) 6L45-20. Various forms of system lockup or display screen "freezes" can occur.Total Bilirubin Assay B) Architect System . there are devices in unit boxes with labels marked size 4 and devices marked '514. product code T5102 (lots R332037. The position of one of the robotic manipulator axes differed from the position determined by the robot controller. The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems. 876386. Non-Cemented Philips Medical Systems (Cleveland). This discrepancy caused the CyberKnife Treatment Delivery There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. On Clinacs running C. 514. 21EXS. The protein C chromogenic value is misassigned in these lots and can result in an erroneous protein C chromogenic activity result. 2009-08-17 2009-08-17 2009-08-17 2009-07-23 49926 2009-07-13 49950 2009-06-22 50114 Type II Type II Type II 1006236-001 S/N'S IT35079. the detector may slide. to its hardware limit. The lot is not stable for the full 30 day period when opened and stored at 2-8 c as recommended.0400 KNRU. the couch can be moved via the float mode when the stereotactic motion disable function is turned on. Damon SS Archwire 227-1029. An investigation has confirmed microbial contamination in one vial of indicator cell. 2009-08-03 2009-07-01 49726 Type II 7892 17411 A) Pediatric Emergency System Kit B) Pediatric Emergency System Flying Carpet C) Emergency System Intraosseus Module Vital Signs Inc.X. 866059. 874678. Precision issues with this lot may result in increased aPTT times across the range of the assay. The kit is intended for use with urine samples not blood or plasma. PN 94400. DBA Viasys Healthcare Inc. and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post-implant. T1202 Trinity Biotech PLC 2009-08-03 2009-04-23 49895 Type II T1202 S067009 Trinclot APTT HS. size 4'. 888414 B) 878586. 40 mm. 2009-08-03 2009-06-29 49905 Type II A) 7730ALS. This may result in a leak at the connection. MIS Diamond Burs have the potential to deform and fracture at speeds above 50. 7700WIO2.Total Bilirubin Assay Abbott Laboratories Diagnostic Division 2009-08-03 2009-07-10 49921 Type III A) 6L45-20. Biosite. 26 mm. The nonconforming devices were comingled during the manufacturing process. 6L45-40 A) All Lots B) All Lots Brightview Gamma Camera Sy. delaying treatment. 8420-107. CLINAC IX H14. The specimen was known to have a bilirubin concentration higher than the linear limit. Stryker Instruments Accuray. CLINAC IX H29 94400 > 10 Numbers.AW Volumeshare2 . 874187. 7730ORG5. 7700PIO2.0300. positive and negative control components of the test kit.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months. 7730MOD. Viasys Neurocare 2009-08-17 2009-08-17 2009-04-30 48986 2009-02-11 49919 Type I Type II N/A 982A0470 > 10 Numbers. Inc. 7730PUR5. Contact Manufacturer Triage Tox Drug Screen PN 94400 Biosite Incorporated 2009-08-03 2009-05-29 50030 Type III A) Aeroset System . Boxes shipped after August 6. 7730GRN5. Inc. Inc.200 OD given in the directions for use. 7700OIO2. mislabeled as 227-1043. Cat. Contact Manufacturer 130. KNTK Reusable Metal Needle Guides & Bushings Sonara Transcranial Doppler System GE Healthcare Cardinal Health 209. Contact Manufacturer Two parts of the tubular packaging could become loose under the shrink wrap that holds the directions for use insert on the packaging tube and could render the product non-sterile. 7700RIO2. The misprint incorrectly states "use EDTA whole blood or plasma sample only". This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal. R332037R and S287001). Contact Manufacturer Fetal Bleed Screening Test Immucor Inc. 2008 are misprinted on the right side of the box flap. 7700GIO2. If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised. > 100 Numbers. A linear high flag (LH) was therefore not generated. 001K to 149K inclusive B) 001K to 149K inclusive.0400. 7730WHI5. Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical neonatal specimen resulting in a value less than the linear limit. 884383 2100C. 7730YEL5 B) 7730FLY C) 7700BIO2. 7730BLU5. 7730RED5. a component of the Cardinal Health custom sterile packs may have been adversely affected as a result of an issue during the packaging process. Complaints of particulate matter in the indicator cells. under the influence of gravity. If the wire harness is pinched such that the conductive wi Damon SS Archwire 227-1043 Synchromed II Implantable Infusion Pump 2009-08-03 2009-08-03 2009-05-01 49956 2009-07-14 49972 Type III Type II 227-1043 8637 20994915 > 100 Numbers.series version 7. Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the assay. Product Code T1204 Varelisa MPO ANCA A) Bypass TGH Kit B) Valve TGH Kit Clinac IX Radio Therapy Delivery System Trinity Biotech PLC Phadia GMBH Cardinal Health 2009-08-03 2009-08-03 2009-08-03 2009-05-25 49896 2009-04-09 49897 2009-07-13 49952 Type II Type III Type II T1204 17696 A) PC30CG'XXX' B) PC30VP'XXX' R324001 32 Varian Medical Systems. For lot KNRU. Surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure. there are devices in unit box Operator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereotactic positioner. that are actually size 3. Contact Manufacturer Tina-quant a Apolipoprotein A1 Roche Diagnostics GMBH 2009-08-03 2009-07-17 49761 Type III 3032612122 All Lot Numbers Trinical Reference Plasma T5102 Trinity Biotech PLC 2009-08-03 2009-05-21 49894 Type II T5102 R332037. 245F to 366F inclusive C) 245F to 366F inclusive. S287001 Triniclot APPT S. the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect.000 rpm. which is part of the Broselow/Hinkle Pediatric Emergency System. IT35226P 8420-107-120. 4003 S/N: 3000033364 to 3000038740 . No. w/ 3/8" Crystal & Detector Caudal Cephalic Uniglide Femoral Component.> 10 Numbers. 427075BU7.Stryker Ireland 2009-08-17 2009-07-27 50100 Type II 18-3200 A) > 10 Numbers. equipment alerts. 53000-F1 B) 5300P-E1. DSL GE Healthcare 2009-08-31 2009-08-31 2009-07-20 50075 2009-08-04 48251 Type II Type II 1049109. 349890BU4. 53S00-E1. 429328BU8. 38386027. 8650 B) 8015 C) 8120 D) 8300 E) 8000APM. System cannot be recovered without service intervention. 432687BU2. which could subject the patient to additional non-invasive examinations. The factor V Leiden control template may fail to meet the validity criteria set by the macro compo Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors. 53STP-E1 71117083 A) 8600.B) > 10 Numbers. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used. 53S0P-F1 G) 53NT0-E1.0 Siemens Healthcare Diagnostics Inc. 405584BU4. 2080-0025. 53S00-F1 F) 53N0P-E1. 39195027 B) 37820027.Hardware Diagnostic Systems Laboratories Inc. 2225881 > 10 Numbers. 28575801 All Prior To 2009 Excluding 08KM20464 & Excludi The markings on the gauge are incorrect. D 750. The failure of the speaker eliminates audio alarm tones for parameter violation. 970308E. The spherical diameter feature was measuring out of specification (oversized). 364939BU9 28635501. Con A) 417372BU0. Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. The PTFE beading material is a processing aide used during hydrophilic coating. 53N0P-F1. Inc. 970302F. 1051158. 38129027. 2080-0040. sample ID. 397054BU8.3 index units and specimens with 0. 3) Specific ESD protection circuitry may result in an over or under infusion. Roche Molecular Systems. Inc. 2080-0035. 2080.Twin-Pass Dual Access Catheter Vascular Solutions. Stryker has become aware that the third party supplier. Cardinal Health 2009-08-17 2009-08-17 2009-07-15 49969 2009-07-28 49979 Type II Type II GE Medical Systems SCS 2009-08-17 2009-07-31 49983 Type II A) Innova 4100 IQ . 8100LVP F) 8210. R1049110.0mm Direct Measuring Gauge A) Alaris Patient Care System-ID Module B) Alaris Patient Care System-Server Module C) Alaris Patient Care System-PCA Module D) Alaris Patient Care System-ENTDAL CO2 E) Alaris Patient Care System-Pump F) Alaris Patient Care System-SPO2 Module G) Alaris Pa A) Innova 4100 IQ . Contact Manufacturer WB0029 . 2030-6540.0 instrument. 53NTP-E1R. 53ST0-E1. 2009-08-17 2009-07-20 49974 Type II 100034941 All Versions A) Advia Centaur B) Advia Centaur XP Updated recall # 49196 previously posted on 200907-06. MRL Jumpstart Welch Allyn Protocol. 2080-0020. 2030-6525. 419496BU5. 1049124. Contact Manufacturer A) 2080-0015. 419496BU5. patient sample results may be reported with an incorrect result value resulting in Manufacturer has determined that specific lots have shown decreased specificity for negative populations. D 850 3272-O10001. CPU errors involving involuntary table movements. 2080-0060 B) 2030-6516. did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. 53N00-F1. Contact Manufacturer F) > 10 Numbers. 347469BU9. Contact Manufacturer B) > 10 Numbers. Factor V Leiden Kit on LightCycler 2. Contact Manufacturer D) > 10 Numbers. 406451BU5. Inc. or error codes. 417895BU0 A) 417372BU0. 39195027 3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. 2225864. 1051157. The beading is to be removed followed by a visual inspection prior Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique. U1049110 DSL-10-2000 M3335PF N/A > 10 Numbers.8 index may be incorrectly identified as reactive for total antibodies Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightCycler 2. 4) Certain fluids solidify in the pumping mechanis A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & image processing. 69850MA6. Contact Manufacturer Compax 40E Table A) Cancellous Bone Screws B) Gap Plate Screw Update recall # 49712 previously posted on 200908-03. 38129027. 398530BU6 B) 409881BU0. 1) Occluded tubing may cause medication not to be delivered. 5300P-F1 C) 530T0-E1. 530T0-F1 D) 530TP-E1. 20306545. Inc 2009-08-17 2009-07-24 49994 Type III 36101790001 14674120 Operon D850/750/752/B810 Surgical Table Berchtold Medizen-Elektronik GMBH 2009-08-17 2009-02-03 50000 Type III B 810. for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw.Main Unit B) Innova 2000 Cardiovascular System Smith & Nephew. Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue light on the control knob. 530TP-F1 E) 53N00-E1. Contact Manufacturer C) > 10 Numbers. 2009-08-17 2009-07-31 50202 Type II Active Cortisol Enzyme Immunoassay Kit 3. The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry. 2030-6560 A) 53000-E1. 38386027. 53NTP-F1. 64076ES3 A) > 10 Numbers. Inc.5 to 0. 2080-0055. Contact Manufacturer Easylink Informatics System Siemens Healthcare Diagnostics Inc. Contact Manufacturer G) > 10 Numbers. 2080-0030. Contact Manufacturer E) > 10 Numbers. the system cannot be restarted. 2030-6520. 2030-6555. 970302E. 2009-08-17 2009-07-02 49872 Type I 5200 > 10 Numbers. 1049110. 2030-6550. 398530BU6 B) 397054BU8. Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. 3270-O10002. 437542BU4.Main Unit B) Innova 2000 Cardiovascular System GE Medical Systems SCS 2009-08-17 2009-07-31 50099 Type II A) 2335129 B) S1872LC Delta Ceramic Ball Heads Howmedica Osteonics . M Series Remstar Heated Humidifier System Respironics Inc. 970311-E 2208203. The discrepancy may not be apparent to the user and could result in incorrect placement of the K-wire. 417895BU0. GE Medical Systems LLC Howmedica Osteonics Corporation 2009-08-17 2009-08-17 2009-07-31 49649 2009-07-03 49712 Type II Type II 59658ES5. 2030-6535. 2009-08-17 2009-07-30 50054 Type II 970300E. the user might choose not to continue operating the device. 2030-6530. 2080-0050. As such. R1049109. If this occurs. as well as repetitive beeps to indicate pulses when monitoring SP02 (oximetr 4. 2009-08-17 2009-08-04 49917 Type II Speakers in VSM300 Vital-Signs Monitor failed to produce sound. Contact Manufacturer 0045. U1049109.53S0P-E1. 2) Misprogrammed infusion caused by ignoring the warning message. 405584BU4. 406451BU5. 354853BU6. 8220 G) 8110 A) 2335129 B) S1872LC A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers G) All Serial Numbers H) All Serial Numbers A) Vital-Signs Monitor with Rate and Map B) Vital-Signs Monitor with Rate/Map Printer C) Vital-Signs Monitor with Rate/Map/Printer/Temp D) Vital-Signs Monitor with Temp and Printer E) Vital-Signs Monitor with Nellcor F) Vital-Signs Monitor with Nellcor SP Welch Allyn Protocol. different. floorlock retracting to unlock position. 63221ES6. causing therapy to be delayed or Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may impact patient safety. 53NT0-F1. D 752. 2009-08-17 2009-06-10 49196 Type III A) 07566733 B) 07566733 A) 37820027. 53ST0-F1 H) 53NTP-E1. The positive bias of approximately 0.0T Signa HDX MR System . 3261-O10036 Welch Allyn AED10 Defib.. As a result. For DXC 600i Versys Hip System Femoral Head Staphaurex Plus 150/450 Test Kits VGM 19" Monitor Updated recall # 48079 previously posted on 200905-25.V12. For DXC 800 C) Tube Assembly 142. 0500-120-025. 669024. Welch Allyn Protocol.A) Stryker Pain Pump 120cc Catheters B) Infusion Sets For Stryker Pain Pumps C) Stryker Pain Pump 270cc Catheters D) Exfen Catheters E) Stryker Pain Pump II Infusion Sets F) Stryker Pain Pump2 Kits Stryker Instruments 2009-08-31 2009-06-23 49458 Type II A) Dyonics Powermax Elite Motor Drive Unit B) Dyonics Mini-Motor Drive Unit C) Dyonics Power Ultralight Motor Drive CyberKnife Robotic Radiosurgery System Smith & Nephew. 0501-416-050 D) 0500-050-000. 352166. Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit. 21107. 352165. TT8. Additionally there is the potential for the painpump to under-infuse pain medication. 51356. SS8. Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed. The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released. A10038 B) 4764. Calibrator 3. Teleflex Medical Surgical Scissors Teleflex Medical 2009-08-31 2009-07-06 49787 Type II 352164.61. 71361 B) 51033. Contact Manufacturer Roche Diagnostics GMBH Teleflex Medical 2009-08-31 2009-08-31 2009-07-31 50171 2009-07-31 50274 Type III Type I Heartstart MRX Defibrillator/Monitor Philips Medical Systems 2009-08-31 2009-07-02 50290 Type II > 100 Numbers. Conmed Linvatec 2009-08-31 2009-08-05 50376 Type II IA-2000-S Conmed Linvatec Arthro-Knife Linvatec Corporation D.A. V2. 36103. 5-16128. 5-16035. 70-0074-103. OO8.S. 0500-250-000 C) 0501-100-000. 2009-08-31 2009-06-22 50252 Type II A) 0500-100-000. 31036. 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel. Roche Diagnostics GMBH 2009-08-31 2009-08-31 2009-08-31 2009-07-10 50348 2009-07-26 50203 2009-08-13 50168 Type III Type II Type II N/A TD-WST-01 A) 3666794 B) 04800842190 5031656190 A) 5-16028. 2013) 70-0071-103. NN8. 5-16141 B) 5-15301. Cook Sydney IVF Culture Oil Siemens AG 2009-09-14 2009-02-11 47071 Type III 10093754. With Expiration Dates Of July 2009 to August 70-0076-003. 682455 A) 71358. This device is not currently licenced for use in Canada. These lots are included in Anti-Cardiolipin IGM Test Kit. 70-0077-103. Inc. Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). The position of one of the robotic manipulator axes differed from the position determined by the robotic controller.B. Without routine operational checks. A) N/A B) N/A C) N/A C202 A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the cleaning process had been completed prior to sterilization.A A) All Serial Numbers B) All Serial Numbers Lots #153989 And Above A) > 10 Numbers. Do not interpret the result after 3 minutes". 71360. V. 70-0072-003. This action is being conducted because the potential exists for residual buffing compound to be present on the surfaces of the femoral head. 2009-08-31 2009-07-27 50231 Type II Zimmer Inc. The manufacturer has updated the instructions for use to state "read the result at 3 minutes. PTY. 70-0071-113. Conmed Linvatec 2009-08-31 2009-08-05 50381 Type II > 10 Numbers. It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the attachment points. J438910 657819. Endoscopy Division 2009-08-31 2009-07-26 50208 Type III Accuray. VV8. When this happens the stylus or EHS HP i The Lasertek 5000 has been classified as a class II device in Canada. Software defect 24578. extended radiation or useless image.12.A. V. > 10 Numbers. WW7. 2009-09-14 2009-03-31 47702 Type II K-SICO-200 In Aquilion One System.11. PP8.A. 70-0078-103 2013) TSX-301A/2 > 10 Numbers. 71357. resulting in unintentional movement. endangering the patient or operator. Inc. lot CLM3-156. Contact Manufacturer (Numbers With Expiration Dates From July 2009 to Sept. A10038 801802802 N/A VG930M A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers 60378581 J477610. Sireskop SX/SD Updated recall # 47071 previously posted on 200906-22. 352168. Wellcolex Colour Salmonella Oxidase Touch Sticks A) Integrated Power Console (ENT) B) Integrated Power Console (NT) Beckman Coulter Inc. MM9.B. unintentional radiation. Contact Manufacturer Aquillion One Toshiba Medical Systems Corporation 2009-08-31 2009-08-11 50342 Type II Clearview HCG Unipath Limited 2009-08-31 2009-06-29 50405 Type II 506788 All Lot Numbers. 21087. 5-16037. 352167. V12. 51508 Lasertek 5000 TDWorkstation Working With Sebia Hyris A) CoaguCheck XS Instrument B) CoaguCheck XS Plus Monitor Elecsys Anti-CCP reagent Kit A) Sheri-I-Bronch Endobronchial Tube Kit B) Sher-I-SWIV Double Swivel Tracheal Tube Scalp Laser Technidata S. Communication issued to affected facilities but no product return requested. lot CL-863 only.A. 70-0075-003. 0500120-000.51. 0501-120-000. The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC systems due to an accumulation of crystals. 31 11 676. 0500-110-000. RE30858302 N/A A) 1898001 B) EC300 J438110. the TDWorkstation sends the total protein result to the instrument for a wrong patient. Oxoid Limited Medtronic Xomed 2009-08-31 2009-08-31 2009-08-31 2009-04-03 50093 2009-04-20 50095 2009-07-27 50207 Type II Type II Type III RE30858301. Contact Manufacturer (Lot #'s 70-0073-003. 3111668 21005. The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resu In certain external transport use environments. XX8. Inc. 5-16041. 540-155-000 A) 72200616 B) 7205357 C) 7205971 28000 A) All Lots B) All Lots C) All Lots D) All Lots E) All Lots F) All Lots There is the potential for the catheter to break. V2. XX7. For DXC 600 B) Tube Assembly 142.. UU8. This procedure may include liquid into the meters which can lead to the creation of electrical bridging between heater pins. 0525-010-000 E) 525-250-000. Contact Manufacturer B) > 10 Numbers. May produce weak positive or false negative results. may also be affected. Remel Europe Ltd. 34170. WW8. Higher than usual viscosity of culture oil may lead to difficulty in culturing.12. . Cook Australia. 2009-08-31 2009-08-31 2009-08-31 2009-08-06 50277 2009-03-27 50094 2009-04-21 48079 Type II Type II Type II A) 4764. The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. MM8. a rough square finish to the scissor tips rather than a smooth tip. A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as taphylococcus aureus. Ltd. 5-15401 M3536A N/A V. 21040. Penetrating liquids or sprays entering the system may lead to malfunction of the system. 352178 425-2020 RR8. 5-16039. 41021 A833541 William A. 680190. 352169. Error 103 (karel e-stop detected) and error 3 Manufacturer has identified a defect. 0500-140-000 B) 0500-200-000. A healthcare facility reported their end-to-end targeting accuracy was out of specification. An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. In a specific case. J359510 S/NS > QC2082880001 Remel Europe Ltd. QQ8 CL-863 Anti-Cardiolipin IGM Test Kit Bio-Rad Laboratories Diagnostics Group 2009-08-31 2009-07-27 50175 Type II A) Tube Assembly 142. the mechanical/electrical connection between the pads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate.V2. 525-500-000 F) 0525-125-000. 21110. or an error may occur at the time of scan setup when sure exposure 3D is used. due to the problem of software and other. could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft. Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits. 516139. V12. a part of the imagerelated information may be abnormal. 660081.11. Contact Manufacturer Lightwave Ablator IA-2000-S Linvatec Corporation D.A. Previously the instructions allowed tests to be read up to 10 minutes. A10038 C) 4767. 5-16135. 5-16137. 0501140-050. 27-159. 27-162. 90402 It was discovered during final review of the product 4027. 2009-09-14 2009-08-14 50432 Type III 114607000 Hydrodissector Cannulas Hurricane Medical 2009-09-14 2009-05-14 50440 Type II 4027 Ultrapower Diamond Wheel Bur Linvatec Corporation D. 27260. During radiation treatment the usual data were not visible on the operator station display. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monitor through the N-DISVE A) All Versions And Lot Numbers B) All Versions And Lot Numbers > 10 Numbers.4 B) 250 (Versions 6. in fact. Curved Jaw With Cord B) Plasmakinetic Curved Jaw Open Forceps C) Plasmakinetic Straight Jaw Open Forceps D) Plasmakinetic Angle Jaw Open Forceps Gyrus Acmi. A) All Versions And Lot Numbers In rare instances. but the system did not mark the treatment as interrupted. 27-157. X300 Ultrasound System Draeger Medical Systems. 2009-09-14 2009-07-31 50356 Type II A) 250. 27-262. 27-199 D) 27-154. 2009-09-14 2009-08-14 50406 Type II Bomimed Inc.5T MR Systems . May become loose. 8288054 In rare instances. 27-198.5T with other coils increases the B) 8985. 042309. X150. 2009-09-14 2009-04-30 50420 Type II Magna-FX Cannulated Screw Fixation Zimmer Inc. Only a portion of 1 lot did not meet product specifications for silver content. Contact Manufacturer 10037. Contact Manufacturer F) > 10 Numbers. 7021-393 Datex Ohmeda Carestations Interface GE Healthcare Finland OY 2009-09-14 2009-04-14 47422 Type II M1079844 Coloplast became aware of an InterDry AG stability test failure in that a sample submitted for testing contained no silver. Contact Manufacturer Warmer. 27158. making driver engagement impossible. 10183. 915005PK. 27-160. 042209 A customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked with the plastic mould. M006550161.1 And Less) B) 250. A) VNS Model 250 Programming Software B) VNS Demipulse System Programming Software HTA System Hi-Art System Cyberonics Inc. 10130. 27-155. 7021-292. 2009-09-14 2009-08-18 50595 Type II A) 915000PK. > 10 Numbers. Inc. 27-156. 300. 8256.5T MR 042709. 27134. Contact Manufacturer G) > 10 Numbers. A problem may occur when an order of long duration (those continuing for several days) is discontinued. 110009. 915010PK B) 3103PK C) 3104PK D) 3105PK A) All Lots Prior To 2009-08-14 B) All Lots Prior To 2009-08-14 C) All Lots Prior To 2009-08-14 D) All Lots Prior To 2009-08-14 . lot 090402 that the wrong product was issued for packaging. 8442.1 And Less) M006550160. Wh Latch bar on centrifuges may have been improperly assembled. The treatment was then stopped at around the 4min mark. A) VNS Demipulse SYS Programming B) VNS Demipulse SYS Programming Software A) Gyroscan Intera ACS 1. 99220. Contact Manufacturer The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. 27-135 C) 27-196. 27-261. 10072. 27-133. product 2027 was inadvertently retrieved and packed as a product 4027. disabling safety feature which prevents customers from opening centrifuge while it is spinning. 5572. 10236. 10169.Respiratory & Monitoring Solutions GBU 2009-09-14 2009-08-18 50527 Type I A) Model/Catalog #: 4220 B) Model/Catalog #: 4245 C) Model/Catalog #: 1110 Pedicap. 2009-09-14 2009-08-11 50356 Type II A) 250 (Versions 6. Due to the configuration of the buffer storage in local memory it may not set the status of the future tasks to "done".5 Tesla MR System B) Intera 1. Contact Manufacturer D) > 10 Numbers. Pedicap 6 A) S/W version 7. 2009-09-14 2009-08-10 50507 Type II Covidien LP . a system diagnostic test using model 250 programming software (v 7. 22658.5T and Gyroscan Intera ACS 1. 300477 A) PKS Seal Open Forceps. 27-303. Lot numbers listed are the affected anesthesia circuits. Contact Manufacturer E) > 10 Numbers. 3000. 8379. Company already have send corrective fax-back to MDB. Contact Manufacturer This device ID was included because of the error on device ID #23037. Contact Ma 1789435 Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating from catheter. 2000/3000.1 and earlier) may report "lead impedance: ok" when. 10014. 60471710 Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex broached into the head of the screw. 2200/3200. 27-197. 5465. A similar ophthalmic cannula. M006560200. 2009-09-14 2009-09-14 2009-07-20 50549 2009-08-12 50581 Type I Type III 1250. Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the formulas determining flow volume are described in the included manual addendum. 5438 The combined use of the Synergy Flex-M/Shoulder Coil 1. in fact. 27-132. 27-161. In this rare instance it will c A recent modification to Pedicap end-tidal co2 detector may result in increased resistance to airflow through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels. Inc. 5418. Contact Manufacturer B) > 10 Numbers. so that the indicator paper will not change colo After a brief intense fire in a neonatal unit in the United States.1 C) S/W version 7. 27-264 7910 A) > 10 Numbers.A. 10566 patient.1. 8672. 110129 8192744. 5220.1. 250 V7. normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering the Possibility of thermal injury to patient resulting from fluid leakage at the cervix around the sheath. 1500. 21-307. normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering the A) 5354. 27-315. This applies to all Intera 1. 79 FMT 8648375 All Serial Numbers 302351. The metal shim between the jaws may detach during the procedure and fall into the surgical field. 27304.1 B) S/W version 7.Coils Aquesure Disposable Filters Cyberonics Inc.1 B) All Versions And Lot Numbers and earlier) may report "lead impedance: ok" when. a system diagnostic test using model 250 programming software (v 7. It has been reported that the detached shim may be undetected and be left behind in the patient. 250 V7. 27-263.A) Van Sonnenberg B) Flexima Hydrophilic All Purpose C) Flexima Hydrophilic Drainage D) Flexima Hydrophilic Biliary Drainage E) Flexima Hydrophilic Drainage Kit F) Flexima Hydrophilic Nephrostomy G) Flexima Hydrophilic Nephrostomy Catheter H) VTC Nephrost InterDry Ag Boston Scientific Corporation 2009-09-14 2009-03-23 47710 Type III Coloplast A/S 2009-09-14 2009-07-28 50228 Type II A) 20-307. 2000. chance of RF interaction and heating up of the coil. 21-306. 303316. even though the rad on indicators were active. The catalogue # 7021-392 was wrongly listed under device ID 406636 instead of 406639. Siemens Medical Solutions USA. 3200.V.4 A) N/A B) N/A N/A Philips Medical Systems Nederland B.1 > 10 Numbers. 27-131. 101212. 200. Conmed Linvatec 2009-09-14 2009-08-04 50380 Type II 7021-092. This may result in possible burns of the 8240. > 10 Numbers. Inc.B. an ECRI investigations concluded the stabilet was the ignition source for the fire. 27-316 B) 27-124. Infant Radiant G40. M006560201 101264 Boston Scientific Microvasive Tomotherapy Incorporated 2009-09-14 2009-09-14 2009-08-05 50466 2009-08-13 50472 Type II Type II Clay Adams Dynac III Centrifuge Becton Dickinson And Company 2009-09-14 2009-08-17 50475 Type III 420104 A) Anesthesia Manager B) PACU Manager C) Critical Care Manager Pedicap / Pedicap 6 Picis Inc. Contact Manufacturer C) > 10 Numbers. Brainlab AG 2009-09-14 2009-09-14 2009-08-17 50456 2009-08-12 50497 Type II Type I EPLUS-FP A) 20630 B) 20630 A) 50130 B) 1950 C) 2507 D) 11555 E) 40051 F) 11859 G) 11846 H) 11781 I) 186706 J) 13075 K) 12384. M00448110. 65050 (Syringe) A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A M00448100. Emax 2 Plus System . Conmed Linvatec 2009-09-14 2009-08-14 50401 Type II A) 16320-122 B) 16320-131 C) 16320-293 D) 19500-474 E) 16320-573 F) 16320-573 G) 16320-583 MC5057 A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N) N/A O) N/A P) N/A Q) N/A R) N/A S) N/A T) N/A U) N/A V) N/A W) N/A X) N/A Y) N/A A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A N/A Sterile barrier in the packaging may be compromised. intended conical collimator may lead to serious injury or death of the patient Power cords may crack and fail leading to potential risks of electrical shock. Contact Manufacturer G) > 10 Numbers. q-curve D) Wiseguide Guide Catheters. contralateral F) Wiseguide Guide Catheters. and the audible sound is heard and/or the indicator light is on. brachial D) Impulse Angiographic Catheters. Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or the failure to mount and verify the correct. Contact Manufacturer D) > 10 Numbers. Contact Manufacturer B) > 10 Numbers. Contact M > 10 Numbers.femoral E) Impulse Angiographic Catheters. Delay in setup and therapy interruption and fires which may also occur in an oxygen-rich environment. when used with various Conmed Linvatec electric handpieces may cause the handpiece to self activate.A. which can lead to leaking and possibly to breakage of the glass barrel. . cls G) Wiseguide Guide Cat MC5057 Universal Cable Boston Scientific Corporation 2009-09-14 2009-08-07 50383 Type II Linvatec Corporation D. Contact Manufacturer E) > 10 Numbers. 20792 M) 12618. The foot control cable lacks the shield connection from the cable to the connector body. If foot switch is not depressed. Boston Scientific EP Technologies 2009-09-14 2009-08-05 50601 Type II Potential to deliver RF energy without depressing the foot switch. radial E) Wiseguide Guide Catheters. Contact Manufacturer C) > 10 Numbers. 20709 L) 11971. the foot switch is not functioning properly. Cover caps exhibited visible cracks post sterilization. Sterile barrier in the packaging may be compromised. Contact Manufacturer F) > 10 Numbers. amplatz B) Impulse Angiographic Catheter.B.internal F) Impulse Angiographic Catheters. 12391.left G) Imp Boston Scientific Corporation 2009-09-14 2009-08-07 50383 Type II A) 08526-01 B) 16391-100 C) 16391-11 D) 16391-02 E) 16391-201 F) 16391-190 G) 16391-117 H) 16391-174 I) 16391-40 J) 16391-180 K) 16391-203 L) 08526-150 M) 08526-21 N) 08526-01 O) 08526-201 P) 08526-190 Q) 08526-146 R) 08526-40 S) H749085263002 T) 08526-1 A) Wiseguide Guide Catheters.A) Expo Angiographic Catheters. amplatz C) Impulse Angiographic Catheter. 20678 64999. 20679. The possibility that a sufficiently worn/damaged Universal Cable MC5057.Foot Pedal A) Brainscan Radiotherapy System-Software B) iPlan RT Dose-Planning Software A) Oximetrix 3 System SO2/CO Computer B) Lifecare PCA 4100 Plus Infuser C) Lifecare 5000 Plum Infusion Pump System D) Plum XL E) Omni Flow 4000 Plus IV Medication MS F) Plum XL Micro/Macro With Data Port XLD G) Plum XL Micro/Macro Infusion (XLM) H) Plu The Anspach Effort Inc. Implant Direct LLC 2009-09-14 2009-09-14 2009-08-11 50526 2009-08-18 50598 Type II Type II The glue joint between the glass and the metal can be insufficient on some syringes. multipurpose C) Wiseguide Guide Catheters. The lack of shielding may result in radiated emissions exceeding CISPR11. Contact Manufacturer Hospira Inc. 2009-09-14 2009-08-20 50517 Type II Galileo 500ul Syringes A) Screwplant Implants B) Screwplant Healing Collars C) Legacy Healing Collars D) Screwindirect Implants E) Screwplus Implants F) Screwdirect Implants G) Replant Implants H) Replus Implants Cobra Electrosurgical System Immucor Inc. bypass B) Wiseguide Guide Catheters. M0048400 SN C08301701901 A) N/A B) N/A A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N/A A) > 100 Numbers. The affected lot numbers of the reagent. 2009-09-14 2009-09-14 50611 Type I Capture-R Ready Screen (4) HeartStart MRx Defibrillator/Monitor Immucor Inc. Contact Manufacturer The glue joint between the glass and the metal can be insufficient on some syringes. BBB98125.1080. A defect in Version 6. This occurs because QC passed but was repeated and failed prior to the 24-hour expiration period established for the first QC. There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. PL1080 LOT 6087. BBB97731. 5971. 8596SC >10 Numbers. N/A QC may not be reset after reported QC failure. Ivory B) Portex Tracheal Tube. 2009-09-28 2009-08-11 50427 Type II Haemonetics Corporation 2009-09-28 2009-08-31 50666 Type II Sutureless Connector Intrathecal Catheters and Revision Kits Medtronic Inc. A physical interference between the SC Catheter Connector and the Isomed Pump prevents the SC Catheter from completely connecting to the Isomed Pump even though it may appear to be connected and feel secure. Philips Medical Systems 2009-09-14 2009-09-14 2009-08-18 50618 2009-08-18 50623 Type II Type II A) 100-105-025. PL1081 LOT C6340. 2009-09-28 2009-08-27 50614 Type I 8578. 8731SC. Cementless Size 7 Corin Limited 2009-09-28 2009-08-06 50619 Type III A) Version 4.A. can lead to leaking and possibly to breakage of the glass barrel. PL1080 LOT 6240. 100/126/025.07 Uniglide Tibia. Product performance is not affected. Medtronic has determined that Sutureless Connector (SC) Intrathecal Catheters and Revision Kits are not compatible with Isomed Infusion Pumps. Contact Manufacturer A) Advia Centaur System Software Class 3 B) Advia Centaur XP System Software Class 2 C) Advia Centaur XP System Software Class 4 D) Advia Centaur XP System Software Class 3 E) Advia Centaur System Software Class 2 F) Advia Centaur System Software Class 4 A) PowerProMax Battery Modular Handpiece B) PowerProMax Battery 2-Trigger/Full F HP C) PowerProMax Oscilator Handpiece D) PowerProMax Reciprocator Saw Handpiece E) MPower Battery Two Trigger F) MPower Battery Sternum Saw G) MPower Battery Handpieces H) PowerPro Battery Trigger Handpiece Siemens Healthcare Diagnostics Inc. Contact Manufacturer F) BBC98784. 549020-2. 559010. 190985. PL1081 LOT C6375 >10 Numbers. 09066916 E) 04911855. Insufficient process control of the sterile barrier (blister lid) sealing process. 469785 Reagent part # 469785 lots M810083 and earlier. BBC07409. 6. 100-111030. The rare possibility exists for a pump encoder failure to go undetected and cause a pump to spin rapidly and possibly infuse anticoagulant to a donor. TestOxidase Reagent Staph Xtra Latex Kit Pro-Lab Diagnostics Pro-Lab Diagnostics 2009-09-28 2009-09-28 2009-06-30 49922 2009-06-30 49925 Type III Type II PL. Immucor Inc. 6. Oral/Nasal. 100/127/ 0066802. PL1081 LOT 5927.0 Software D) Version 6. 183847 Software Version 6. Contact Manufacturer A) I-Stat Kaolin Act Cartridge B) I-Stat Act Celite Cartridge MCS+Mobile Collection System. 100-111-035. Internal testing conducted by the manufacturer has determined that Advia Centaur V. Contact Manufacturer NACN The manufacturer has determined there is a remote possibility that certain handpieces may self activate. 2009-09-28 2009-08-28 50676 Type III Linvatec Corporation D. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC reference preparation for plasma proteins. normally clear or tan in colour. 2009-09-14 2009-09-14 2009-09-14 2009-08-25 50640 2009-08-14 50625 2009-08-24 50639 Type III Type II Type III N01IAB Stratus OCT A) A32898 B) A32898 C) A32898 442840 186620. BBB97730. LN 9000 Abbott Point Of Care Inc.390 PL. 100/134/035 E) 100/112/030. 100/126/030. This also causes a weekly self diagnostic test to run hou Some of the bottles had already gelled and were unusable.0 and Advia Centaur XP V. An inconsistency was noted in the i-Stat System manuals regarding the volume of saline used to flush an indwelling line and the volume of blood to be discarded for clearing the line when testing coagulation cartridges. PL1081 LOT 6067. The affected lot numbers of the reagent. Contact Manufacturer D) >10 Numbers. BBC98787. 2009-09-14 2009-08-24 50657 Type II Unexpected positive reactivity with this lot of product. 549030-2. Oral/Nasal F) Portex Tracheal Tube. This has occurred just one time in over fifteen million procedures in the past 10 years. PRO6400 H) PRO5200. . Murphy Eye. The devices were shipped with an incorrect configuration file.B. 2009-09-28 2009-09-28 2009-08-24 50713 2009-08-28 50717 Type III Type II 65051 87000 PL1080 Lot 6066. PL.0 A) >618967 B) >618967 C) >618967 M901330 And Higher Beckman Coulter Inc. 100/126/035 C) 100-141-025. PRO5400 525.Murphy. 07G81-02 B) 07G01-01. Pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process. 5884. 100/112/035 F) 100/127/025. 2009-09-14 2009-08-28 50663 Type II 469600. in certain situations reports generated will have incorrectly labelled OD (right eye) or OS (left eye). 09000-110-EWC A) All Lots B) All Lots >10 Numbers. 6136 Galileo 1000 Microliter Syringe Galileo Echo Blood Bank Analyzer Immucor Inc.0 Software B) Version 6.1081 5824. The devices have been sealed in blister packs. Invalid test result due to unexpected negative reactions with the positive control observed with this lot. BBB99925.0 of Stratus OCT instrument and review software. over the time. Oral/Nasal. Contact Manufacturer H) >10 Numbers.US00535118 Bond-1 Primer/Adhesive Stratus OCT Tomographer Vers. BBC07410 B) >10 Numbers. This has caused a shift in quality control results and patient results for Ig Phenobarbital And Drug Calibrator 1 Beckman Coulter Inc. M3536A A) All lots prior to Sept 2009 B) All lots prior to Sept 2009 C) All lots prior to Sept 2009 D) All lots prior to Sept 2009 E) All lots prior to Sept 2009 F) All lots prior to Sept 2009 Smiths Medical International Ltd. 100-111-025.0 Software F) Version 4. 09066916 D) 078-A010-07. disarming the 'flashing red x' and audible alarms when they are powered by AC or DC power and have no battery or low battery capacity. random access mode) with the Access Accutnl assay. 8709SC.e.0 Software E) Version 4.0. BBB97734. Siliconised C) Portex Tracheal Tube. Results Drug Calibrator part # 469600 lots M810440 and may vary from -3% to +17% with different reagent and calibrator lot combinations when earlier. may display graininess that could be misinterpreted as a false positive result. BBB99622. 07G01-02 09000-100-E. 2009-09-28 2009-08-05 50289 Type II 549015-2.0 Software C) Version 6. Beckman Coulter Inc. 078-A001-14 F) 04911855. 078-A001-14 A) PRO5100M B) PRO5200M C) PRO5300M D) PRO5400M E) PRO6202 F) PRO6450 G) PRO6200.0. 559030-2 A) 07G81-01. have shown a purple discolouration. 6038. Conmed Linvatec 2009-09-28 2009-08-14 50403 Type II A) 04911855. The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate when run in conjunction (i. 09066916 C) 078-A010-07. Contact Manufacturer E) >10 Numbers. 0066812 M3535A. 559020-2. There is a remote potential for a suction catheter to become lodged K226 Serial numbers US00533518 . BBB98124. 078-A001-14 B) 078-A010-07. PRO5100. PL1081 LOT 6237. 100-105035 B) 100-111-020. The recovery of the standard has shifted. LLC Carl Zeiss Meditec Inc. BBD08568 G) >100 Numbers. 100-141035 D) 100/134/030. Spinnaker Elite Flow Directed Catheter Boston Scientific Cork Ltd. BCD-470. 4. measured against the established gas chromatography flame ionization detect Boston is sending safety alert to customers to re-emphasize the device's approved indications and remind that this product is not intended or indicated for use with glue or glue mixtures.0 system software is missing range flags and no reflex testing after restoring definition files and reflex for Hepatitis B surface antigen (HBSAG) is not updated. 100-105-030.0 Software A) Unicel DXI800 Thyroglobulin Antibody II B) Access System Thyroglobulin Antibody II C) Unicel DXI600 Thyroglobulin Antibady II Synchron CX Immuno-Protein Calibrator Pentron Clinical Technologies. PL1081 LOT 6127. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications.A) Portex Tracheal Tube. which. PRO5300. PL1081 LOT 6088.Siliconised D) Portex Polar Preformed Tracheal Tube E) Portex Tracheal Tube. 190582. Clear Smiths Medical International Ltd. PRO6300.0 Software A) BBB97037.N/A 2. 100-141-030. Contact Manufacturer C) >10 Numbers. 18-286. Manufacturer received 21 complaints that catalyst portion of TempBond Clear with Triclosan syringes was polymerized and therefore unusable. A) Unipolar Intramuscular Leads B) Enterra Gastric Stimulation Leads C) Enterra Therapy GastricC Stimulation IPG A) Virtuoso Dual Chamber ICD B) Concerto CRT-D C) Virtuoso Single Chamber ICD R Series Defibrillator/Pacemaker/Monitor Medtronic Inc. Both may result in inaccurate or inappropriate treatment.0 Cellestis Ltd. Contact Manufacturer Applied Medical Resources Corporation 2009-09-28 2009-06-09 50115 Type II C0R36 1084426. TDXSR-CG. LSP46. Sequencer for MOSAIQ 1. LLC 2009-10-12 2009-10-12 2009-09-01 50725 2009-08-03 50774 Type III Type II N/A N/A A090504Z Version 2. 18B) >100 Numbers. 2009-10-12 2009-08-26 50811 Type II A) 18-251. Contact Manufacturer C) >10 Numbers. the wheelchair may exhibit a tendency to do one or more of the following: 1) veer to one side. 2010. which could lead to overestimate of size of breast lesion. The problem is a defect in the RTP Import functionality (SEQUENCER) during the import of an RTP plan. 18-300. Siemens Healthcare Diagnostics received customer complaints regarding Immulite / Immulite 1000 total T4 kit assay where the barcode did not correspond to the kit barcode lot number. 4300-50 B) 4351 C) 3116. S/N AF09B006791 3257280. 18-288. Failure to display the patient's ECG could delay delivery of defibrillation or pacing therapy. 18-298. This affects PCR Eleva system connected to a RIS. 9093001.5. The subject defect did not impair the accuracy of or the ability to use QA mode. 2011. This issue may present in the affected devices as reaching the recommended replacement time (RRT) earlier than expected. 8. The identity of other medical devices or accessories used in the event is unknown. 3269811 351 Medtronic Inc. Contact Manufacturer B) S/N'S A8177079. Contact Manufacturer 290. The correct expiry date is November 29.30. There is an intermittent series of events in which a print or store event failure may cause the following to occur: A) The last image of a patient study can be stored with the next new patient study performed. 200995 A) Renegade Fiber Braided Microcatheter B) Renegade Hi-Flow Microtainer Boston Scientific Cork Ltd.6. 1. it appears in the report as R Testis Mass 2 in English only. S/N AF08L006574. 18-303 . 7425G A) D164AWG B) C174AWK C) D164VWC Zoll R Series A) >10 Numbers. TDXSR-MCG. UA233.11. S/N AF08G005269. 18-253 A) >100 Numbers. 5183859-4. HIT A) >10 Numbers. M8281004. 200334. Stryker has identified a need to provide specific instructions for initiating power to the Calcar Planer prior to engagement with bone in the cutting edge.1. LSP47M. 1085506. Measurement values provided by Seno Advantage Workstations 1x. 2. 1082348 Cell II of this product tests positive with the direct coombs test which interferes with antibody screening procedures causing false positive results. 8354008 N/A Uric Acid Assay A) Calcar Planer Surgical Protocols B) Accolade Surgical Protocol Randox Laboratories Ltd. Normally problem detected because the "active" name of patient is displayed.0 Heater Wire Adaptors Fisher And Paykel Healthcare Ltd. Sequencer for MOSAIQ 1. potentially leading to serious injury.15. 3258772. On some chairs the stability lock feature may not be engaging properly or consistently. 8. 200979. Manufacturer is replacing these adaptors with new. Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%). 2. An investigation confirmed the complaints. 18302. 2009-10-12 2009-09-08 50793 Type II 10041461 200252. R series may display an ECG fault 7 message and fail to display the ECG baseline. Sequencer for MOSAIQ 1. 3277455. 3229807. Contact Manufacturer C) >10 Numbers. If the change to the plan had been to parameters other than dose per fraction. from IEC1217 to IEC601). Contact Manufacturer B) >10 Numbers.1. LKT45 Quantiferon-TB Gold In-Tube Ilumavision Software Ver. Contact Manufacturer S/N AF07F001253.g. C) When a distance ratio or area ratio measurement is performed with L Testis Mass 2 measurement label. 2009-09-28 2009-09-14 50818 Type III LKT41. treatment to incorrect volume could result. Incorrect imaging resulting from 3rd party digital image (Dicom) incompatibility. 8. Contact Manufacturer A) >10 Numbers. S/N AF09B006789. 8. TDXSR-CG-HD.41.1. 5183859-5 Workcell Siemens Healthcare Diagnostics Products GMBH 2009-10-12 2009-09-09 50779 Type III A) >10 Numbers. more advanced product. 2009-09-28 2009-09-28 2009-09-28 2009-08-24 50727 2009-09-04 50731 2009-08-27 50644 Type III Type III Type III 70226 L2KAO2 10-0020 169053 217 Sequencer for MOSAIQ 1. HIT B) 8. Imtec Imaging. Potential incorrect patient identification on report. and Omnifit Eon Surgical Protocols. Pouch seal (top seal) may be breached.5. It was observed that there were a higher than expected number of false positive results with lot A090504Z and the presence of higher levels of endotoxins was found. which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. 2009-09-28 2009-09-04 50734 Type II A) 4300-35.07.60. LSP48 B) LASST 154107 A) N/A B) N/A Acuson S2000 Siemens Medical Solutions USA. Secur-Fit Max/Secur-Fit Plus Max. Contact Manufacturer B) 18-285. batch 154107. 3268505. Affected devices may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. 2) rock forward onto its front riggings. A cannula tip had fractured during a gastric bypass procedure.0 & 2. However. TDXSR-MCGHD.1. 18-252. Inc.07. C0R36 15x100mm Kii Optical Access Sys Varian Medical Systems. and/or 4)fall forward or to one side and injure the user. A9062007. 18-291. 2009-09-28 2009-09-09 50790 Type II Zoll Medical Corporation 2009-09-28 2009-09-02 50795 Type II TempBond Clear with Triclosan Kerr Corporation 2009-09-28 2009-09-09 50813 Type III 33351 Immulite System-Total T4 Assay Siemens Healthcare Diagnostics Products Ltd. TDXSRV-HD A) Aria Software B) Aria Offline Review Software Updated recall # 49074 previously posted on 200906-22. 3) drive in an unintended circular motion. An anomaly exists in the software. Sterile barrier in the packaging of affected product may be compromised. Sequencer for MOSAIQ 1. D) When more than 4 measurements of the same label are performed they will not appear on-screen or on the printed report. Enterra Therapy leads may wrap around or perforate the bowel.11. Inc.6.1 may be incorrect when applied to magnification images acquired on non-GE digital mammography systems.15. If the stability lock feature does not engage properly. was incorrectly labelled with an expiry date of August 28. 2009-10-12 2009-07-23 50850 Type II 900MR800 All Lot Numbers A) AW Volumeshare B) AW Volumeshare2 Streamlab Analytical Workcell GE Medical Systems SCS 2009-10-12 2009-09-15 49927 Type II A) S30321ZK B) 5183859-3. N/A TDXSR-HD. 18-289. Possibility that choice of patient will be changed when using filtered work lists. as well as to provide specific instructions for rasping dense bone and/or narrow intra medullary canals for the Accolade Surgical Protocol. Contact Manufacturer B) >10 Numbers.40. Sequencer for MOSAIQ 2. the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. 2009-09-28 2009-05-09 49074 Type II A) 8.50. The resulting fragments were recovered and the event did not directly result in patient injury. Contact Manufacturer B) >10 Numbers. S/N AF08J005776. which converts the Field between coordinate systems that swap the X and Y axes (e. Omnifit HFX. 200926. 200288.. B) If the first patient's last image had measurement results they will appear on the next patient's image.Search-Cyte Duo Reagent Red Blood Cells Immulite 2000 System-Androstenedione AS Sequencer Biotest Medical Diagnostics GMBH Siemens Healthcare Diagnostics Products Limited Impac Medical Systems Inc. Howmedica Osteonics Corporation 2009-10-12 2009-10-12 2009-09-15 50863 2009-09-14 50823 Type III Type II UA233 A) LSP42.00 A) N/A B) N/A A) PCR Eleva S B) PCR Compano Eleva TDX SR Power Wheelchair Philips Medical Systems DMC GMBH 2009-09-28 2009-02-23 46769 Type II A) PCR ELEVA S B) PCR ELEVA PLUS Invacare Corporation 2009-09-28 2009-09-02 50704 Type II TDXSR. The recall is initiated to provide important new safety information and patient management recommendations related to the potential for bowel obstruction and/or perforation in a small percentage of Medtronic Enterra Therapy System patients. Customer complaints regarding Dimension Vista Systems connected to a Streamlab Analytical Workcell where it has been observed on rare occasions an intermittent low result. which include surge protection hardware that will reduce the risk of breathing circuit heater wire malfunction. 18-299. 2. A7274009. 18-259 1077-1 >100 Numbers.The device is a cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. A) Definium 8000 Digital Radiographic System B) Proteus XR/A General Purpose Radiographic C) Revolution XR/D Digital Radiographic System Synex II System . have been distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piece. Hypergel 5 gram.808. GTOB20042. though testing has not shown this.808. lot 012709123 was found to contain mixed instruments. was notified by their supplier. Ltd.808. Model IS2000 Intuitive Surgical Inc. 04. 04. 0901034284. KG 2009-10-26 2009-09-22 51025 Type II M1091316.005. taper .808. H74937912519900.808. The stretchers have the potential for the bushing in the braking system to fracture. H74937911715900. A Division Of Datex Ohmeda Inc.Central Body GE Healthcare 2009-10-12 2009-09-21 47780 Type II Synthes (Canada) Ltd. 025L D) 022L.007. Synthes (USA). 025L H) 243 I) 022L. 04. 025L E) 243 F) 022L. Pouch seal (top seal) may be breached. 12082341. The isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. Alloy segregation can affect material strength. of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively. 2259976. If the pedal seizes. LE15 Sorin Group Italia has recently identified a weakness in the plastic packaging tray used for the Revolution Centrifugal Blood Pump that might lead the packaging tray to crack.04 (20/. 04. The laboratory confirmed the source of contamination was the device. M1091335.003. lot numbers 08d22-156-32913 and 08d22-157. Contact Manufacturer B) >100 Numbers. LC16.5 Transverse Connector Zimmer Spine Austin. Linvatec Corporation D. H74937912618900 YG18568 GTOB20042 360500 Boston Scientific Corporation 2009-10-12 2009-04-14 48011 Type III Steris Harmony LL500/700 Surgical Light GT Obturators Hypergel 5 Gram Steris Corporation Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Molnlycke Health Care AB 2009-10-12 2009-10-12 2009-10-12 2009-09-14 50864 2009-09-25 50931 2009-09-22 50961 Type III Type III Type III A) >10 Numbers. Da Vinci S Surgical System. M1091365 N/A Connection Bracket 1180. KP08. Contact Manufacturer C) >10 Numbers. 0812102798.L. Bacterial contamination (Pseudomonas mendocina) in the affected device. taper . 025L 0905220164. LA12. Contact Manufacturer B) >100 Numbers. The cause of this play. This action is being conducted because a small quantity of titanium alloy was discovered to have a discrepancy from the alloying process at another manufacturer. 12089752. Contact Manufacturer 038K6170 A) Transport Stretcher B) M-Series Stretcher C) Trauma Stretcher D) Eye Surgery Stretcher Express SD Premounted Stent System Stryker Medical 2009-10-12 2009-08-31 50938 Type II A) 0737-000-000. Contact Manufacturer 12709123 08D22-156-32913. Table locks may not actuate.B. is too large. 04. 025L G) 022L. causing tabletop to unexpectedly float in either the lateral axes or both the longitudinal and lateral axes. 04. S3918LD 04. 5131070. A software coding error in P7 caused the error for the MTM grip.A.36AO 2009-10-26 2009-09-30 51053 Type II 1180. Packaging for the applicable devices may not include a written copy of the product directions for use. 2009-10-12 2009-09-22 50964 Type III 1302-55M 55QJ A welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged and fall.808. 025L J) 022L. Sigma Diagnostics 2009-10-12 2009-10-12 2009-08-26 50941 2009-09-21 50914 Type II Type III 18-257. product code 360500. Severity in risk analysis control document (RAC) scored low leading to less strict supplier inspection and process control requirements. which is responsible for locking the accessory to the operating room table interface. which could result in patient or operator injury. Update: The manufacturer now requests return of the affected devices. 12054580.808. 025L B) 022L. 12085875. which could result in the brake/steer pedal seizing.009. observed an electronics subsystem failure that resulted in partial intermittent closure of the instrument grip (IS2000 system). Cracks in the packaging tray can compromise the product sterility.04) and size 20.006. 04. size 20. 04. 1.08) obturators.808. Contact Manufacturer C) >10 Numbers.808. 12070363.008. 12129028 >10 Numbers.010. 08D22-157 Sterile barrier in the packaging of affected product may be compromised. is that the hole in the lock washer. 12054585. Giraffe & Panda T-Piece Resuscitation System Ohmeda Medical. Moulding flash during manufacturing of T-piece at supplier caused out of specification aperture. 2. Conmed Linvatec 2009-10-26 2009-08-14 50401 Type II 537702 N/A . H74937911614900. Contact Manufacturer All Lot Numbers A) 022L. H74937912618150. 04.Renegade Fiber Braided Microcatheter Histopaque 1077-1 Boston Scientific Cork Ltd. S3918KD/KE C) 2351505. 025L C) 022L.08 (20/. 0901034285 12045170. 2259988. used with Conmed Linvatec Electric Handpieces may cause the handpiece to self activate. Terumo Cardiovascular Systems has received three reports of tubing disconnecting from the pump inlet of the Sarns Disposable Centrifugal Pump during cardiopulmonary bypass.360AO N/A MC5057 Universal Cable Updated recall # 50401 previously posted on 2009-09-14. 12089749. 2009-10-26 2009-09-23 51015 Type II A) 2259988-2. 0812101547.001. 12054587. The product. GT Obturators.011 A) LCRCM B) LCRCM C) LCRCM D) LCRCM E) L2KCRP2 F) LCRCM G) LCRCM H) L2KCRP2 I) LCRCM J) LCRCM 50300700 A) >10 Numbers. 12073173.004.002. Contact Manufacturer D) 0811100540. 0906240184 Synthes (Canada). Inc. The Connection Bracket show too much mechanical play at the operating room table interface for some procedures. Siemens Healthcare Diagnostics received customer complaints regarding instabilities of high sensitivity C-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots. 5131070 B) 2259973-3. 0738-000-000 B) 1007-000-000 (SM104) C) 1027-000-000 D) 1079-000-000 H74937911515900. Speedlink 5.808.808. It has been suggested that the metal used to manufacture parts from lot 55QJ may have a similar problem. 2009-10-12 2009-09-23 50981 Type II A) Immulite System-Reactive Protein (CRP) Assay B) Immulite 2500 System-HIH Sensit CRP Assay C) Immulite 1000 System-Cardiac HSCRP Assay D) Immulite System-Cardiac HSCRP Assay E) Immulite 2000 System-Cardiac HSCRP Assay F) Immulite 2500 System-HSCRP Assay G) Immulite 1000 System-High Sens CRP Assay H) Immulite 3000 Systems-High Sens CRP Assay I) Immulite System-High Sensitivity CRP Assay J) Immulite 1000 System-C-Reactive Protein Revolution Centrifugal Blood Pump Siemens Healthcare Diagnostics Products Limited 2009-10-26 2009-09-11 50797 Type II Sorin Group Italia S. 04. 12045167. Intuitive Surgical Inc. 2009-10-26 2009-07-01 51026 Type III IS2000 N/A Sarns Disposable Centrifugal Pump Terumo Cardiovascular System Corporation 2009-10-26 2009-07-06 51040 Type II 164275 KN10. A sufficiently worn/damaged Universal Cable MC5057. 12082319. Maquet GMBH & Co.R. the braking system may become inoperable and/or steering around corners may become more difficult. BBB99622.2 or below. The innermost packaging has been shown to remain intact. Contact Manufacturer H) > 10 Numbers. XTEN. Sterile barrier in the packaging of the affected product may be compromised. Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. Ortho Clinical Diagnostics is aware of one confirmed report of misreported patient results with the Engen Laboratory Automation System. LA12. PRO6300. Contact Manufacturer C) > 10 Numbers. The product is labelled as 25 mm in length but the files are actually 31 mm in length. 2009-11-09 2009-11-09 2009-09-30 51119 2009-10-08 51151 Type II Type I M001171060. Advisory letter was sent to customers of Revlite System with Revision E1 software. 07311MA. the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. In this case. M001171080. Contact Manufacturer 687218 Update: The manufacturer now requests return of the affected devices. Five complaints involving braze joint failures of AdvanSync Telescopic Rod Assemblies resulting in a recall. M001171120 724-E >100 Numbers. The manufacturer has determined there is a remote possibility that certain handpieces may self activate. rather than the inner pouch. 6470117. ARD 567910910 A) K7058 B) K7022 C) 10445904 D) 10445888 164275 ENGEN A) 07310MA. LC16. Contact Manufacturer Amplatz PTFE-Coated Guidewire Gyrus Acmi. Inc. Tubing disconnecting from the pump inlet of the disposable centrifugal pump during cardiopulmonary bypass. Conmed Linvatec 2009-10-26 2009-08-14 50403 Type II A) PRO5100M B) PRO5200M C) PRO5300M D) PRO5400M E) PRO6202 F) PRO6450 G) PRO6200. 060971299. Contact Manufacturer RL-1094 Equalizer Balloon Catheter Manual Pulmonary Resuscitator (MPR) Boston Scientific Cork Ltd. The company has become aware that there is the potential that over time. Testing indicates the integrity of the packaging was maintained by an inner o-ring seal. 2009-11-09 2009-10-09 51184 Type II 6470114. 6470115. 08029MA. LE15 JCT20Q3J A) Antistreptolysin O Assay B) Antistrepolysin O Assay C) IGM Flex Assay D) ASL Flex Reagent Sarns Disposable Centrifugal Pump Engen Automated Sample Handling System Siemens Healthcare Diagnostics Products GMBH 2009-10-26 2009-09-24 50979 Type III Nobel Biocare received several complaints from customers. HLX 3004. Unomedical Inc. 2009-11-09 2009-08-25 50973 Type III 13BX 96158DB Endoclamp Aortic Catheter Revlite Edwards Lifesciences Hoya Conbio 2009-11-09 2009-11-09 2009-10-01 51118 2009-03-31 49248 Type II Type III EC1001 N/A >10 Numbers. placing the product. part number 13BX. or immunoglobulin M analytes. On some units of the Manual Pulmonary Resuscitator (MPR). Contact Manufacturer G) > 10 Numbers. the outer box is labelled with the errant 96158DB lot number while the inner pouches are correctly labelled as lot 96159DB. Amplatz PTFE-Coated Guidewires. There is a slight possibility of outer pouch failure during shipping. 08336MA D) 07177MA. PRO5300. 2009-10-26 2009-09-24 50977 Type III ARD 567801093. Inappropriate handling may cause a crack on the front pivot of the Acrobat 2000 spring arm. Contact Manufacturer 03-25 Bryan Cervical Disk System Medtronic Sofamor Danek USA. BBD08568 G) >100 Numbers.B. 08252MA. M001171100. BBB98125. the system may not complete change to new wavelength as requested.A) PowerProMax Battery Modular Handpiece B) PowerProMax Battery 2-Trigger/Full F HP C) PowerProMax Oscilator Handpiece D) PowerProMax Reciprocator Saw Handpiece E) MPower Battery Two Trigger F) MPower Battery Sternum Saw G) MPower Battery Handpieces H) PowerPro Battery Trigger Handpiece Updated recall # 50403 previously posted on 2009-09-28 Impression Coping Closed Tray Linvatec Corporation D. BBB98124. 060971304. After investigation it was determined that one batch of Impression Coping Closed Tray Nobelactive INT RP Q6x9mm was mis-packaged. which could result in the introduction of an inner pouch having non-sterile outer surfaces into the sterile field. KP08. Contact Manufacturer D) > 10 Numbers. sold as lot 96158DB. ARD >10 Numbers. BBC07410 B) >10 Numbers. Once this occurs there will be no vacuum applied to the suction manifold so the primary function of the affected rover canister is lost. Possibility of the balloon rupturing during use. declaring that if PTP keypad is pressed while the wavelength window is green. If this were to occur. PRO5100. If the force becomes too high the manifold cannot be rotated therefore it cannot be inserted or removed. 08043MA. may have been mis-packaged with product from lot number 96159DB. BBC07409. 6470116. into the sterile field. 2009-10-26 2009-09-28 51016 Type III K1021 Received customer complaints regarding inaccurate results with the Bun Flex Reagent cartridge lots 09154AE and 09187AA. Contact Manufacturer E) > 10 Numbers.8. incorrect sample ID’s may be electronically written to the radio frequency ID tags on the sample carriers. Contact Manufacturer .A. HLX 3005 Maquet S. Contact Manufacturer F) > 10 Numbers. 080902357.The test results may be falsely depressed or elevated. 6470118 >10 Numbers. Proper dispensing technique must be followed. BBB97734. BBB97731. 060976084.A. Contact Manufacturer H) >10 Numbers. BBC98787. Termo Cardiovascular System Corporation Thermo Fisher Scientific OY 2009-10-26 2009-10-26 2009-07-14 51040 2009-10-06 51117 Type II Type I AdvanSync Orthodontic Device Ormco Corporation 2009-10-26 2009-10-05 51125 Type III 600-4000 080901333. When used with TCAutomation software versions 2. the MPR may loose its ability to generate the positive pressure necessary to function properly. 08336MA B) 07311MA. BBB99925. Cover caps exhibited visible cracks post sterilization. Inc. It has been reported that the outer pouch seal may be breached. 070981416. ARD 567801094. Contact Manufacturer F) BBC98784. 08029MA. a buildup of surgical waste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. Contact Manufacturer A) Screwplant Implants B) Screwplant Healing Collars C) Legacy Healing Collars D) Screwindirect Implants E) Screwplus Implants F) Screwdirect Implants G) Replant Implants H) Replus Implants Updated recall # 50598 previously posted on 200909-14 Implant Direct LLC 2009-11-09 2009-08-18 50598 Type II A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A A) > 100 Numbers. 070981417. 07177MA C) 07310MA. 060976079 09187AA Dimension Vista System-Urea Nitrogen Assay Siemens Healthcare Diagnostics Inc. 080902356. 09077MA KN10. 080901335. PRO5400 N/A Nobel Biocare AB 2009-10-26 2009-05-21 48621 Type II A) BBB97037. 09077MA. BBB97730. Contact Manufacturer D) >10 Numbers. Contact Manufacturer E) >10 Numbers. Contact Manufacturer C) >10 Numbers. PRO6400 H) PRO5200. Contact Manufacturer 567910901. antistrepolysin o. 08252MA. Contact Manufacturer B) > 10 Numbers. 08043MA. Lexicon K-File Neptune 2 Ultra Rover Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics Stryker Instruments 2009-10-26 2009-10-26 2009-09-29 51017 2009-10-06 51120 Type III Type II KF01025 0702-001-000 811000105 >10 Numbers. Under certain conditions the software falsely elevated the results particularly if the preceding serum sample has a higher volume and concentration of beta2-microglobulin. The date range of distribution for the affected products is 2007/04/26 to 2007/08/01. 10151. After further review it has been determined that this action by the manufacturer is not considered a recall under the definition of recall. M001761141. An incorrect sensitivity limit has been assigned which is reagent specific and could cause results to be erroneously elevated between 17% and 40%. 10052. 123620 There is potential for a crack on the front pivot of the Acrobat 2000 spring arm installed with a Blue 130 series surgical light that could cause the surgical light to swing freely. Also Trading As Wallach Surgical Devices Siemens Healthcare Diagnostics Products GMBH Computerized Medical Systems. it is possible the graphic beam representation and dose display do not agree with the edited field on the text page.3 ng/ml/hr. 10044.6. Midas Touch Needle Electrode Siemens AG Siemens AG Fisher And Paykel Healthcare Ltd. M001761401. 756008025.A. Printed range on the label is 5. Contact Manufacturer . 10142. Fractions delivered on the Artiste might not be recorded in Lantis and subsequently patients might be mistreated. IW934. Notifying users in Canada of updating cleaning instructions for the IW900 Series Infant Radiant Warmers./S. 00001719 Guider Softip Guiding Catheter Medi-Tech Boston Scientific Corporation 2009-11-09 2009-10-07 51219 Type II Syngo Imaging XS Syngo Imaging XS Heater Wire Adaptors Updated recall # 50850 previously posted on 200910-12. WITH SUFFIX JEU A) 10024 B) 10040 All Infant Warmers in Canada. 10063. 93477.0 -7. M001761422. Inc. M001761501. 10148.5 . D05589 & D50233 >10 Numbers. Potential software problem with Acuson and Sonoline Antares systems product version 5. Inc.L. The actual 4mm Aimer is marked as 6mm and the actual 6mm Aimer is marked as 4mm. 10164 104 96 279 075 020 29 N/A >10 Numbers. 2009-11-09 2009-10-19 51331 Type III 9015 W72407 Endo Femoral Aimers Smith & Nephew. 10047. 10146. 72201716 A) TCD Drainage Catheters B) SKATER Single Step Drainage Set PBN Medical Denmark A/S 2009-11-09 2009-09-22 51091 Type II A) 716084020 B) 756007025. IW930.13 software will not communicate reliably through either channel 3 or 4. The correct range is 4. M001761122. (DBA CMS. 10147. 10048.X. Inc. This could cause intra operative confusion due to the mislabeling. GE Medical Systems Kretztechnik GMBH & CO OHG 2009-11-09 2009-11-09 2009-04-30 48348 2009-10-21 51227 Type III Type III 100 90 480 A) H48651PT B) H48661N 71642220 92241. Endoscopy Division 2009-11-09 2009-09-22 50942 Type I 72201714. Contact Manufacturer B) >10 Numbers. 2009-11-09 2009-10-19 51278 Type II N/A 123574. the sterile barrier in the packaging (pouch) that contains the vial may be breached. 113469 >100 Numbers. Specific product codes and lot numbers of the Endo Femoral Aimers may have been improperly marked indicating the wrong size and part number. 95248 A) S/N D00229 B) S/N D04842. 10152. The recall was initiated due to recent tests that indicated some Midas Touch Needle Electrodes with modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user. Inc. Penumbra initiated voluntary field removal of the original catheter design from the marketplace. 011970 Wallach LL 100 Cryosurgery Device Von Willebrand Reagent XIO Radiation Treatment Planning System Cooper Surgical Inc. If an auto port is created for a beam on focal. Inc. 2009-11-09 2009-10-15 51245 Type III A) Artiste Syngo RT Therapist Assist B) Artiste Syngo RT Therapist IW900 Series Infant Warmer Siemens Medical Solutions USA. A known reason of failing Tonometer Prisms is the use of disinfectants not approved and not released by Haag-Streit.0. This might lead to irritation of cornea and in rare cases to reversible corneal erosions.10. 95243.>10 Numbers.A. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals. 756512020 For product code 72201714: (L) 50278012 For product code 72201716: (L)502780141 and (L)50278014 A) >10 Numbers.0 & Higher A) Acuson Antares Software Version 4.-5.0 B) Acuson Antares Main Unit/5.R. 10046. The Renin Activity Control provided with the kit has an incorrect range printed on the label. 2009-11-09 2009-11-09 2009-09-23 51246 2009-09-07 51309 Type III Type III A) 08162807 B) 08162815 IW910. 756506025. This issue only occurs when the monitor's analog output is set to external.X. Inc.0 A) Voluson E8 Ultrasound System Main Unit B) Voluson E8 Expert Ultrasound System Intertan Hex Screw Siemens Medical Solutions USA. Contact Manufacturer BCI 9015 4-Channel Analog Output Cable Smiths Medical PM.3. Contact Manufacturer 900509-5 OUBD23 537675. Hagg-Streit received 3 reports concerning leaking Tonometer Prisms.. for affected products.6 ng/ml/hr. Inc. but is considered a product withdrawal by the manufacturer. Contact Manufacturer 1225.0 with cardiac option installed below software version 200. 537682 N/A Release 4. IW932. Contact Manufacturer Gammacoat Plasma Renin Activity 123I RIA Kit Diasorin Inc. M001761301. The problem originated in 2007 and all internal product was corrected. M001761541. 10134 B) 114573. 10163. M001761162. M001761441. 10162. REF. 1532. M001761322. 00001717. 10144. Defect rate is 0. M001761341. In Europe. Inc. 2009-11-09 2009-09-22 50980 Type III M001761101. Boston Scientific Corp. M001761562 56077943 >100 Numbers. When interfaced via A 9015 cable to an external data collection device. REF-900034. A 9004 monitor configured with CCAP 1. M001761462. vessel trauma and stroke. Haag-Streit. Contact Manufacturer All affected product is packaged within a vial.N. 95071. To inform customers about a potential issue. 10150. 10143. When using combination of 2D-compound resolution imaging (CRI) and a pulsed wave Doppler single gate (PW) with steered Doppler angle.079. Potential loss of single image data of prior examinations when archived to network-attached storage (NAS) or hierarchical storage management (HSM). 756508020. IW980. It is believed that vast swings in environmental conditions can impact catheter products over time.35%. 10064. Oncology Care Systems Fisher And Paykel Healthcare Ltd. which could delay treatment. the displayed velocity scale is incorrect. A potential of a single image of a series is displayed "distorted" after loading to a viewing application. 123612. Use of degraded catheters can expose patients to potential adverse events including a delay in procedure time due to catheter exchange. 10062. Packaging integrity may be compromised as a result of transportation and distribution of the products. 2009-11-09 2009-09-17 51330 Type II N/A >10 Numbers. however the product in the field was not corrected.) The Elekta Group Siemens Medical Solutions USA. IW920. 756012025. 756010025. 2009-11-09 2009-11-09 2009-11-09 2009-10-13 51220 2009-10-13 51221 2009-07-23 50850 Type III Type III N/A 10042. is issuing a safety alert reminding users to follow directions for use. 10051. M001761362. 10043. 10050. Under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimal temperature delivery to the treatment site. 756507025. 070 Neuron Delivery Catheter Penumbra Inc. when receiving the multiple PSV measurements from some ultrasound systems. Syngo Dynamics C. IW950.Contour SE Microspheres Boston Scientific Corporation 2009-11-09 2009-08-28 50810 Type II Maquet Hanaulux Model Blue 130 Maquet S. mainly cool wipes. This recall was initiated as the product description included the word 'captured' and this was not a 'captured' screw. the plan sent to XIO and the beam edited.S.7. AG 2009-11-09 2009-11-09 2009-11-09 2009-09-19 51212 2009-10-13 51218 2009-10-13 51241 Type II Type III Type II REF-900000-900002. Improper storage may cause polymer degradation in portions of the catheter. M001761522.0 Upgrades Goldmann Applanation Tonometer Prism 2009-11-09 2009-11-09 2009-10-08 51249 2009-10-13 51262 Type III Type III A) 05936518 B) 10032746 1000855 A) 112267. Design modifications were made to the Neuron Delivery Catheter in March 2009 to improve the catheter kink resistance. M001761222. M001761201. M001761241. Contact Manufacturer Smith & Nephew. 1533 14630 N/A Olsen Medical 2009-11-09 2009-09-24 51204 Type II 30-1014 011668. M001761262. the absolute value is not being used. Boston Scientific has determined that. IW934.A) Triporteur Star 3 B) Quadriporteur Star 4 TheraScreen K-Ras Mutation Kit A) Online TDM Gentamicin for Roche/Hitachi B) Online TDM Gentamicin (GENT2) for Cobas pRK(Rabbit Kidney) Orthofab Inc. The mixed standard component of the Therascreen Mutation Kit may sporadically generate out-of-range high results when tested with the control assay. 2009-11-23 2009-11-23 2009-10-14 51369 2009-10-20 51408 Type III Type III 7114-0108 00-2357-009-06 L06MT04447. The threaded connector of the battery clip housing can become loose from the battery clip housing thereby creating a potential to interrupt pump function. Contact Manufacturer B) >10 Numbers. Contact Manufacturer Steinmann Pin Zimmer Inc. Users could still acquire data. The void in the foil may lead to suture degradation and the potential for a compromise in the sterility of the product. Systeme PhD EIA/IFA (cat# 426-0246) Insight Software Revision H. lot and batch number identified. 20301 >10 Numbers. The online TDM Gentamicin assays may generate falsely elevated control and patient results when used with the current lot of Preciset TDM 1 Calibrator on the Roche/Hitachi analyzers. 180-32000-22 5366259190 A) 03800504190 B) 04490843190 48-0600 A) >10 Numbers. Roche Diagnostics GMBH Roche Diagnostics GMBH 2009-11-09 2009-11-09 2009-11-09 2009-09-22 50934 2009-09-23 50937 2009-10-07 51194 Type II Type III Type II A) 180-32040-22 B) 180-32000-07. 48511905D >100 Numbers. GE Medical Systems Information Technologies 2009-11-23 2009-10-26 48250 Type II Heartmate XVE And II LVAS Battery Clip Reflex Hybrid Screw Extractor Inner Shaft Thoratec Corporation Stryker Spine SAS 2009-11-23 2009-11-23 2009-10-14 51438 2009-10-13 51370 Type II Type II 418779-010. This action is being conducted because the part number on the locking plate (Zimmer Periarticular Locking Plate System distal lateral tibial plate) is incorrect. CICV4APRO=XXX N/A 48511905B. Contact Manufacturer 480109 Lack of surface treatment on one of the gears of the transmission gearbox. resulting in an inability to obtain the biopsy sample. Operator's manual does not warn against the unintended use of Apexpro Telemetry to monitor SPO2 without concurrent ECG monitoring and does not identify correct alarms and messages during loss of SPO2 data condition.Bioview REV5. 3. Contact Manufacturer B) >10 Numbers. Potential limit switch failure could occur due to collision between lateral plane of Innova positioner and other equipment. Contact Manufacturer S/N 553918BU4 Titan Anchor Accessory Kits Medtronic Inc. and a confirmed event in which the seal was retained in a patient. since they could be erroneously reported as A*0301/A*1101. 2009-11-09 2009-01-21 51217 Type III Gynecare Morcellex Tissue Morcellator Ethicon Inc. This will affect typing results on samples that are Aa*0301 homozygote. IW950. 426-0246 S98-1925-2H N/A All lots are affected A Locus High Resolution SSP Unitray Invitrogen Corporation 2009-11-23 2009-07-24 51366 Type III 47290-10. 2009-11-23 2009-10-23 51411 Type III 18700259 61211489 Therascreen K-Ras Mutation Kit DXS Ltd. CICV3APRO=XXX/XXX . If this occurs it may result in lead migration and compromised therapy for the patient. GE Medical Systems SCS 2009-11-23 2009-11-23 2009-10-16 51391 2009-10-30 51374 Type II Type II MN1610. will produce a false positive band at the correct base pair size in the presence of A*0301 samples. which would result in a warning message and the instrument would shut down. IW930. 2009-11-09 2009-10-09 51327 Type II MX0100 >10 Numbers. The mixed standard component of the Therascreen Mutation may sporadically generate outof-range high results when tested with the control assay. when it should have been etched '2357-09-06'. Contact Manufacturer DK146-01. The test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. This action is being conducted because packages from the identified lot should contain style 5 (trocar-style three point) Steinmann pins. 2009-11-09 2009-11-23 2009-10-13 51252 2009-02-23 47672 Type III Type III 4226-0228. MN1620 S18821AM >10 Numbers. There had also been reports of damage to the screw and/or the plate while attempting to remove the screw. ASP has received user reports about improper times set for each disinfectant cycle. Lane 23 in the 'A' high resolution SSP Unitray. they actually contain style 6 (spadetype diamond point). The part was etched as '2357-09-07'. Notifying users in Canada of an updated test procedure for the power-fail alarm of the IW900 Series Infant Radiant Warmer. 12960028 Bard Magnum Core Tissue Biopsy Needle Innova 2121IQ Bi-Plane Cardio Imaging Bard Peripheral Vascular. The Revision "H" software calculated esophageal amplitudes incorrectly when the user generated a report. DK149-01 . Specific lots of PDS II (polydioxanone) Absorbable Sutures are being recalled because some of these products may have a small void in the foil outer package. Contact Manufacturer All lots Trinest Microplate Incubator And Shaker Wallac OY 2009-11-23 2009-10-21 51375 Type II 1296-0050 12960024. if they are located outside of the standard range. The Reflex Hybrid Screw Extractor Inner Shaft was reported to fail at the threaded tip and fracture in the head of the screw. Diagnostic Hybrids. The protective coating around certain electrical wires inside the Trinest Incubator/Shaker may be worn out due to contact with a round aluminum part rotating during the continuous shaking movement. Some of the needles may exhibit an exposed sample chamber due to extended stylet length from a loose hub connection. model 3550-39. APRSRVR16=XXX. L08ET19936 60594607 A) PDS II Absorbable Sutures B) Coated Vicryl Absorbable Sutures Ethicon Inc. Advanced Sterilization Products (ASP) is sending a letter to all Automated Endoscope Reprocessor (AER) customers to reinforce the importance of properly setting the disinfectant cycle time when using the ASP AER and to remind users to observe the illuminated temperature light during the cycle. which may break x-ray and positioning switches and may not allow exam completion. Contact Manufacturer Apexpro Telemetry System . Inc. MN1616. A Division Of Ethicon 2009-11-23 2009-09-28 51459 Type III 20300. however there was a requirement to install the revision 'I' software upgrade before reports were printed to ensure data was reported (printed) correctly. Ethicon is conducting a voluntary product recall of all lots of Gynecare Morcellex Tissue Morcellator due to the potential for the duckbill seal to become dislodged. IW980 All Infant Warmers in Canada.5mm Periarticular Locking Plate System Smith & Nephew. Smith & Nephew was made aware that all parts were missing the laser etching as identification information.Clinical Info. The revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm. The Rabbit Kidney Culture(pRK). MN1613. 2009-11-23 2009-09-23 50937 Type III KR-41 DK146-01. appeared to also contain another type of cells. There were no issues with the acquisition of the data. Inc. Also Trading As Ethicon Women's Health And Urology Fisher And Paykel Healthcare Ltd. CICV3APRO=XXX. However. Zimmer Inc. Contact Manufacturer IW900 Series Infant Warmer 2009-11-09 2009-09-07 51383 Type III Series With Suffix > IW910. The service manual already includes a requirement for an annual check of the power-fail alarm. IW932. Results passed on integrating lab systems may be erroneous when using competitive tests. which consisted of a monolayer culture of rabbit kidney cells used to grow viruses from a patient specimen in order to detect or identify the virus. DK149-01 A) >10 Numbers. Medtronic has initiated a field action to notify managing and implanting physicians of Medtronic per cutaneous leads for spinal cord stimulation of the potential for separation of the titanium insert from the silicone portion of the Titan Anchor. Contact Manufacturer >100 Numbers. 2009-11-23 2009-10-26 51428 Type II A) Z316H B) J318H A) ACM008 B) ACM473 ASP Automatic Endoscope Reprocessor Advanced Sterilization Products. Inc.1 Bio-Rad Laboratories Diagnostics Group Sandhill Scientific Inc. 47291-10 1145687 Recon Plate 8 X 9mm. 2009-11-23 2009-10-27 51434 Type II 3550-39 >100 Numbers. There had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. IW920.5. >10 Numbers. Contact Manufacturer B) >10 Numbers. For future reference. 01. 2009-11-23 2009-04-06 51399 Type III 1221 >10 Numbers. 2009-12-07 2009-07-09 50862 Type II 01.00214.062. 01. the most probable cause is using a surgical technique which differs from that prescribed in the surgical technique for the Durom Acetabular Cup. user may unintentionally add new images to an approved exam. under certain conditions images will be deleted from PACS or from dictated. 2009-12-07 2009-12-07 2009-11-09 51507 2009-11-06 51588 Type II Type II >10 Numbers.B. 1051158. Excessive heating of the tip of the fixation screws with the standard non-insulated posts may cause minor burning of the contact point of patients during certain higher energy MRI usage. The box contains a reagent bottle and dye pouch. ATS Therapy Unit H) Proficare Pump Unit I) Therapulse ATP Staphytect Plus/Dryspot. 61314067.Software GE Healthcare IT 2009-12-07 2009-10-30 51228 Type II CyberKnife Robotic Radiosurgery System Updated recall # 50252 previously posted on 200908-31. Therapy Unit E) First Step Select . Expiration dating refers to 'use by' dates. J539110. Therapy Unit C) First Step All in One D) ActiV. 00-5880-016-01. 2009-12-07 2009-06-22 50252 Type II 28000 C202 Colleague Volumetric Infusion Pumps Updated recall # 44735 previously posted on 200811-24. when devices from the affected lots begin to expire. This action is being conducted because these components are labelled with a 10 year expiry period when in fact these components expire 5 years after manufacture.C. There have been reports of revisions of Zimmer's Durom Acetabular Cup and the Metasul LDH (large diameter head) femoral head in certain European markets. 2009-11-23 2009-11-23 2009-10-26 51502 2009-09-23 50981 Type III Type I N/A 04. 04. 61341224 Remstar M Series Heated Humidifier Respironics Inc. 01. 04. 01.00214.050. 2009-12-07 2009-11-20 50202 Type II 1049109. R1049110. 00-5880015-02. of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively.008. Based on Zimmer's investigation. Contact Manufacturer Several boxes of RET-Search II (Red-700A) manufactured on July 15. 227800 DR0100M. J055610. 04.060. Conmed Linvatec Zimmer Dental Inc. Power cords may crack and fail leading to potential risks of electrical shock. U1049109.048.00214.808. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller.054.Pump F) Kinair IV G) V. Contact Manufacturer C) 60433397. 00-5880-003-00.808.Femoral B) Nexgen Rotating Hinge Knee .00214. 04. 10499110.A. 04. Complement Control Cells Synex II System .010.009. was notified by their supplier.006.Fixation Post Baxter Healthcare Corporation 2009-12-07 2008-11-24 44735 Type III 2M9163 >10 Numbers. 04. 2009-12-07 2009-11-09 51634 Type II Remel Europe Ltd. 61238956.00214.00214. 61245049. 04.00214. 00-5880-014-01. 01. R1049109.Central Body Updated recall # 50981 previously posted on 200910-12. 00-5880-005-00. a pinch existed between the moving chair back support and the stationary underside of the armrest. 1003937 N/A A) Nexgen Rotating Hinge Knee .056. This field safety notice updates surgical technique instructions. the upper portion of the abutment had fractured and separated from the lower shaft. 60461749 D) 60186249 H5 RET-Search II Sysmex Reagents America 2009-12-07 2009-11-03 51623 Type II ZY9021 Durom Acetabular Cup Zimmer GMBH 2009-12-07 2009-11-15 51631 Type II A) Therakair Visio B) InfoV.808.808.808. 01.A. and the contents of the bottle and dye pouch are of the proper chemical composition for RET-Search II and passed all in-process and final inspection test criteria.808. Test Kits KCI USA.808. Contact Manufacturer Centricity PACS Workstation .5mmd Platform Tapered Abutment Immucor Inc. 04.00214.A-Dec Decade Plus 1221 Dental Chair A-Dec.066 A) M6257763 B) M8260027 C) 227500 D) 340013 E) 215200 F) 216050 G) M8259994 H) M8259988 I) 227080. Synthes (Canada) Ltd. 01. K2030JN >100 Numbers. 1049110. Synthes (Canada).004. Contact Manufacturer Elekta Instruments AB 2009-12-07 2009-10-02 51522 Type II 1003935.808. 00-5880-016-02 B) 00-5880-002-00. 005880-004-00.RDC) were displayed. transcribed or completed status exam. Inc.007. 61252577.808.C. If Dicom node config. J610610 A potential for false positive reactions with some non staphylococcus aureus strains. interruption of therapy and fires which may also occur in an oxygen-rich environment. Zimmer Dental has received field complaints reporting that during application of torque to the abutment.00214.00214. Synthes (USA). Error 103 (karel e-stop detected) and error 342 (Deviation in absolute position value DSE . Accuray.A. The bar code label identified the product as stromatolyser-NR with the same lot number and expiration date.Tibial Plate D) Nexgen Rotating Hinge Knee .052. B Zimmer Inc. A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J577910. 01.064. 04. Contact Manufacturer 61233652.002. Leksell Stereotactic System . The manufacturer has determined there is a remote possibility that the device may self activate.S. 01. Recalls 50114 and 50252 are identical.C. Customers were erroneously provided with version 0719H0166 of the operator's manual instead of the correct version 0719I0166. 00-5880006-00 C) 00-5880-001-02 D) 00-5880-012-01 RED-700A A) >10 Numbers. There is evidence of potential microbial contamination in some vials of complement control cells (lot # 32616). There is no risk to patients who receive these implants prior to January 2010. A healthcare facility reported their end-to-end targeting accuracy was out of specification. . U1049110 K2020YS.005. Contact Manufacturer When the chair back was returned up to the 'patient entry / exit' position. both of which were correctly labelled. based on gram stain results.808.808.00214. 01.00214. 2009 had an incorrect bar code label applied to the product box. 005880-014-02. Advantage. 2009-12-07 2009-11-06 51622 Type III A) 00-5880-013-01.001. Inc. 04.011 D9924 AVACT 32616 All lots Linvatec Corporation D. Some humidifiers may fail to operate due to potential malfunction of the internal connection between the heated plate and the printed circuit board which results in a 'blinking blue light' on the humidifier control knob. Contact Manufacturer 1051157. 01. 61256798. 2-Button Turbo Handpiece Advent 4. DR0850M >1000 Numbers.046.058.003. Ltd. is set to accept.Tibial C) Nexgen Rotating Hinge Knee. 00-5880-015-01. The pilot broach for threading the internal threads of the implant is too deep and extends into the shaft of the screw. delay in setup and therapy.044. Inc.A. 61263053.Femoral. refer to recall 50252. 1049124. The investigation has determined that the product is not manufactured to specification. which may result in the incorrect handling of a wash arm dispense plate motion failure. T119007 . Inc. Oncology Care Systems 2009-12-07 2009-10-26 51422 Type II A) A30260. Contact Manufacturer P) >10 Numbers. Contact Manufacturer F) >10 Numbers. Stryker Endoscopy was aware that the SDC HD picture/video capture device would not be able to assign the correct time/date stamp for saved files after December 31st 2009. Contact Manufacturer B) >10 Numbers. however the system date would be incorrect and users would not be able to correct this issue without a software upgrade. Contact Manufacturer J) >10 Numbers. 3500-500 >100 Numbers. Inc. If the cone beam is acquired using calculation of table shift coordinates will be based on ISOcenter position. Contact Manufacturer N) >10 Numbers. DBA Angiotech 2009-12-07 2009-09-01 50935 Type II Natus Medical Inc. A71457 F) 4771 G) 4772 H) 4773 A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A There has been a trend observed in failure of the pole mount clamp shipped with a neoBlue mini LED Phototherapy Systems. 522HC. Instead of generating a red 'warning' event and stopping sample processing. the system date for all SDC HD units would re-start from October 1st 2001 and begin incrementing from that point onwards. This event would not affect how pictures or videos were captured using SDC HD during surgery. 2 B) Unicel DXI600 Access Immunoassay System Class 3 C) Unicel DXC880I Access Clinical Analyzer D) Unicel DXI800 Access Analyzer Class 3 E) Unicel DXI800 Access System Analyzer Class 2 F) Unicel DXC660I Access Clinical Analyzer G) Unicel DXC680I Access Clinical Analyzer H) Unicel DXC860I Access Clinical Analyzer Dupaque X-Ray Detectable Sponges Derma Sciences. model 94260-19. A) Artiste MV-Syngo RT Therapist Assist B) Artiste MV-Syngo RT Therapist Siemens Medical Solutions USA. Inc. The pump stops delivery when an MNR/MRE alarm message event occurs. Audio alarms will continue to function normally. A) Unicel DXI600 Access Immunoassay System Class Beckman Coulter Inc. A potential safety hazard associated with the use of Spacelabs Medical 19" Flat Panel Displays. Potentially affected results are not flagged. Contact Manufacturer M) >10 Numbers. 2009-12-07 2009-12-07 2009-11-06 51677 2009-09-01 50976 Type II Type II 6651850 950759. some of these clamps have shown stress fractures or broken. Contact Manufacturer G) >10 Numbers. Contact Manufacturer 60001-62656 serial number The complaints were reported as "run off" (non-contiguous) seals.665-1850 Vasculitis Kit Getinge Steam Sterilizer Bio-Rad Laboratories Diagnostics Group Getinge Sourcing LLC. Contact Manufacturer H) >10 Numbers. >10 Numbers. 0788-100-001. This hazard can arise especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids. 0788-100. RTD temperature sensor component was failing prematurely. 433HC. Contact Manufacturer T) >10 Numbers.2 and 4. The response of the two highest points of the kit's calibration curve are the same and consequently very high D dimer values may be underestimated. Contact Manufacturer C) >10 Numbers. 533HC. 2009-12-07 2009-11-16 51668 Type II Received two complaints from a customer indicating that the sponge separated at the end during surgery and was left behind. e. Contact Manufacturer R) >10 Numbers. Bioflex 2200. Contact Manufacturer E) >10 Numbers. These are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of these pumps. When incorrectly used the frame adapter may become damaged which in worst case could make it possible to lock the adapter so it does not properly fixate the frame.All Lot Numbers 0015 3010A. Contact Manufacturer L) >10 Numbers. Contact Manufacturer U) >10 Numbers.A) Accura Breast Localisation Needles B) Hawkins II Breast Localisation Needles C) Hawkins I Breast Localization Needles D) Homer Mammalok Breast Localisation Needles E) Manan Co-Axial Introducer Needles F) Manan Introducer Sheath Needles G) Manan Guidewire Introducer Needles H) Manan Seldinger Needles I) Manan Modified Potts/Cournand Needles J) Manan Galactography Trays K) Skater-Centesis Catheter L) Chiba Style Manual M) Franseen Style N) Green Style O) Spinal Style P) Westcott Style Q) Hawkins III Breast Localization Needles R) Pro-Mag Disposable Biopsy Needles S) Maxi-Cell Biopsy Needles T) Ultracore Disposable Biopsy Needles U) Lorad Needle Guide neoBLUE mini LED Phototherapy System Medical Device Technologies. 833HC 715000 A) 240-050-888 B) 240-050-890 Serial Number 6005 A) All Lot Numbers B) All Lot Numbers Leksell gamma Knife Perfexion A) SDC HD Capture Recorder B) SDC HD Capture Device Elekta Instruments AB Stryker Endoscopy 2009-12-07 2009-12-07 2009-08-18 51437 2009-10-30 51583 Type II Type II Auto D Dimer Kit CRS 126B Trinity Biotech PLC 2009-12-07 2009-08-19 51650 Type II CRS126-B T065095. Contact Manufacturer Vertical Surgical Table Stryker Communications 2009-12-07 2009-11-06 51664 Type II 0788-100-000. models 3010a and 3500 ("pump"). causing the display to go blank.1. to enter the table column. T082003. Contact Manufacturer O) >10 Numbers. Contact Manufacturer Medfusion Syringe Infusion Pumps Smiths Medical MD Inc. the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Contact Manufacturer K) >10 Numbers. A71457 E) 973100. A run off seal is a seal in which the Angiotech applied seal is mis-aligned. This will lead to an incorrect table shift. A71461 B) A71461 C) 4768 D) 973100.g. 633HC. Contact Manufacturer S) >10 Numbers. Smiths Medical has become aware of an increased trend in reports of "motor not running" ("MNR") and "motor rate error" ("MRE") alarm message events with certain Medfusion Syringe Infusion Pumps. 2009-12-07 2009-10-01 51237 Type II A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A H) N/A I) N/A J) N/A K) N/A L) N/A M) N/A N) N/A O) N/A P) N/A Q) N/A R) N/A S) N/A T) N/A U) N/A 10101 A) >10 Numbers. Inc. 2009-12-07 2009-12-07 2009-10-27 51464 2009-11-05 51605 Type II Type III 94675-5 A) 08162807 B) 08162815 4408 A) 10024 B) 10040 Medical Grade Flat Panel Display Spacelabs Medical. The table may experience involuntary movement as a result of fluid intrusion. Contact Manufacturer I) >10 Numbers. The pole mount clamp has been redesigned by the manufacturer and customers of record are being advised to inspect their systems and to order a replacement clamp if necessary. Temperature control of the sterilization process is maintained through the use of the sensor used in the sterilizer jacket and chamber. 961363 422HC. There is a possibility that the internal power distribution circuit board will fail prematurely. On January 1st 2010. Two or more treatment plans with different ISOcenter positions are stored together in one course in Lantis. such as saline or water. 2009-12-07 2009-10-30 51662 Type II 94260-19 >10 Numbers. 3500-415. Bioplex 2200 vasculitis reagent kits could produce false results when analyzing diluted samples. When tightened with excessive force. main treatment plan and boost plan. Contact Manufacturer 733HC. A software issue was identified in system software 4. Contact Manufacturer Q) >10 Numbers. 3500-306. Contact Manufacturer D) >10 Numbers.2. 959261. 2009-12-07 2009-10-08 51773 Type II A) H18. The result is that the final lot tested will pass QC even though it did not undergo complete QC testing. 8.1.6. 3.Clin. Lot number 915417 contains reagent RLD in well three and RLC in well four. A warning letter was sent to the distributor requesting that sales be suspended until a licence has been obtained. Contact Manufacturer D) 291192MR3. H27.1.0T Signa HDX MR System .Oximeter Pod Nonin Medical Inc. Contact Manufacturer SRS treatments occurred with conical collimator accessory not inserted. Beckman Coulter Inc. Contact Manufacturer A) Cup Lot Numbers Starting With "09" Or Later B) Cup Lot Numbers Starting With "09" Or Later C) Cup Lot Numbers Starting With "09" Or Later D) Cup Lot Numbers Starting With "09" Or Later E) Cup Lot Numbers Starting With "09" Or Later A) Signa 1. preventing release of the cable tightening mechanism. 8. KRYP-X-10. Oxoid Limited Doctors Research Group Inc. Also. 10023YR0 >10 Numbers. Contact Manufacturer Medtronic Spine LLC is recalling specific lots of Kyphx HV-R bone cement following complaints regarding extended time to reach the proper viscosity (doughy state) and inconsistency or lack of homogeneity during cement preparation. T1106 Galileo Echo Blood Bank Analyzer Medxl Inc.1. 8.923 SUB COMP 200.0 ml insert cup. >10 Numbers. 8.1.Main Unit C) 1. As a result of increased viscosity of component "A" in some Kryptonite Bone Cement Kits.Clin. 7547YR3.3. KRYP-Z-10 A) M3000LF B) M3335JK C) M3335PB D) M7000BF E) M3000TD F) 2294302 G) M3333TA H) SIGNA HDXT 1. used on Unicel DXC Synchron Clinical Systems. infection.Acc. Siemens confirms that urine sodium results become elevated as urine specimens are run on a sensor. H29 8. this could prolong surgery time. a manually entered sample ID could be assigned to the wrong sample.12. 8704YR9. 274168MR4. Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to nonpure studies.Main Unit E) 1. Contact Manufacturer F) 243409MR0.5T MRI System . bone filler device). Therapists can acquire gantry angle into plan. H29 C) H14. as well as when waiting to deliver the bone cement with the delivery device (e. long. 9948YR1. but with a primary collimator field size setting exceeding outside diameter of that conical collimator.4.3. Trilogy & Novalis Tx B) Trilogy Radiotherapy Delivery System C) Novalis TX Linear Accelerator Varis 4D Integrated Treatment Console Varian Medical Systems. Inc. 11827YR3. 10232008. 278606MR9. Contact Manufacturer B) >10 Numbers.2.5T Excite HD . Contact Manufacturer C) >10 Numbers.8. 8.Acc. Contact Manufacturer >10 Numbers.301 UR09E21238 SP-122. Inc.Clin. 266690MR7 H) 30BD4960 HDMR2675. K820. 06292009. The reagents in wells three (RLC) and four (RLD) of the reagent pack were inadvertently switched during manufacturing. The access 1. might be the cause of some sample wheel motion errors when run using 13x100 sample tubes. 03102009. 247728MR9. 10685YR6. 500849360.0T Electronics H) Signa HDXT 1. Quality control materials not recovering within predefined ranges. 8. Patient treated with wrong gantry angles one day. As a result.Removable Magnet Hires 90K Advanced Bionics. Analyzer C) Unicel DXC660I Synch. 500874926 Oximeter pod has the potential to cause a burn if the pod is in direct contact with the patient. 239046MR6. during surgery or before use. 290992MR7 E) >10 Numbers. CI-1400-01 and CI-140002H) is susceptible to corrosion.Gradients B) 3.2. even without system rights to acquire gantry angle. 2009-12-07 2009-12-07 2009-11-06 51696 2009-10-23 51585 Type II Type III Trinity Biotech PLC Immucor Inc. 270572MR1 B) 7555YR6 C) >10 Numbers.5T MR SYSTEM N/A 702079 05072009.4. K825. 500823174. Under some circumstances.Troponin B) Unicel DXI600 Access Immunoassay System C) Unicel DXI800 Access Immunoassay System Triniclot PT Excel. Two lot numbers of reagents or strips are allowed to be tested while performing QC testing on the echo. Beckman Coulter. Female receptacle end: the terminal contact are not sufficiently recessed and protected from access. 2009-12-07 2009-12-07 2009-10-29 51421 2009-10-22 51584 Type III Type III K800. A) C-Series Clinac.Magnet GE Healthcare Japan Corporation 2009-12-07 2009-11-05 51766 Type II M3335SE Dimension V-Lyte Integrated Multisensor A) Unicel DXC600I Synch.Clin. 07142008. May produce weak positive or false negative results. 246610MR0.6. 10282009 A) HDMR10368. Analyzer E) Unicel DXC860I Synch. C01B Model 7600 . Prothrombin times are prolonged in lot S172057 by about 1. Analyzer B) Unicel DXC880I Synch. 500857064. 1. Received customer complaints regarding Dimension Vista V-Lyte.Acc. 258415MR9. A malfunction with one of the components that may result in the overheating of the 500549361.Sets Clearlink Power Cord Component Of Sesmoid Plasty Baxter Healthcare Corporation Zimmer CAS 2009-12-07 2009-12-07 2009-11-05 51663 2009-11-05 51683 Type II Type II 2C8864 500. or an opened seal that could result in the product not being sterile. 2009-12-07 2009-10-23 51731 Type II Model 7600 Separation of tubing from Distal Clearlink Y-site could occur. The cable portion is not certified North America. 8. Contact Manufacturer There is a potential that the package pouch in the CBC II Blood Conservation Kits may have a pin hole. 8. interruption of or delay in the start of intravenous therapy.Acc. 500849356. 500849358. LLC 2009-12-07 2009-08-25 51652 Type II N/A N/A BHR Streamline Cup Introducers Smith & Nephew.5T Signa Infinity Twinspeed Excite F) Signa 1. if implanted.2 seconds.23 SP2 . 266072MR8.5T MR System . 8. 10272008. a weakened seal. 2009-12-07 2009-11-11 51665 Type II 90128285 S811270 A) Intravenous Infusion Accessory IVMED20 B) Intravenous Infusion Accessory IVMED60 A) Access Immunoassay System . 8. With wrong field size. K835 A) 4767 B) 4768 C) 4771 D) 4772 E) 4773 Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to nonpure studies. the end user may observe difficulty in discharging component "A" from the syringe that it is packaged in.1.Acc. 2. 253630MR8.Main Unit GE Medical Systems LLC 2009-12-07 2009-11-05 50777 Type II Advanced Bionics (AB) is notifying all surgeons. Malfunction when adding CBCT image.0. lat) editing & acquiring for approved plans' selected in treatment administration. The affected units should be monitored and replaced if necessary. KRYP-Z-03. 242181MR6 G) 6690YR2. Present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert. 8. unintended radiation is given to patient outside the outer edge of cone. Inc.Hardware D) Discovery MR750 MR System .0. 2009-12-07 2009-12-07 2009-12-07 2009-11-06 51708 2009-07-07 51737 2009-09-17 51492 Type I Type II Type III 87000 BR0064A KRYP-X-03. 2009-12-07 2009-10-16 51774 Type II . >10 Numbers. SP-197 CBC II Blood Conservation Kit Stryker Instruments 2009-12-07 2009-11-13 51764 Type II 225-414-000 Kyphx HV-R Bone Cement Medtronic Spine LLC 2009-12-07 2009-11-09 51643 Type II C01A.1.10833YR2.g. 7964YR0.5T Infinity Excite MR System G) Signa Excite 3. The male plug that plug to the power supply mains is missing a label. 05272009. Signa HDE 1.0.5T Signa HDX MR System . which may result in blood loss. 10312008.1 SP2. 239043MR3.1. H29 B) H14. or with conical collimator accessory correctly mounted. 256216MR3. this could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition. Analyzer D) Unicel DXC680I Synch.3.1.6. Buretrol IV Solution Adm. Analyzer Siemens Healthcare Diagnostics Inc. clinicians and patients that the removable magnet component of the HiRes 90k cochlear implant (model no. The identified lot number may mechanically seize up. A) >10 Numbers. 8. Inc. 2009-12-07 2009-12-07 2009-08-06 51651 2009-11-06 51706 Type III Type I A) N/A B) N/A A) A78803 B) A78803 C) A78803 T1106 87000 A) N/A B) N/A A) 915417 B) 915417 C) 915417 S172057 N/A Galileo Echo Blood Bank Analyzer Oxidase Touch Sticks Kryptonite Bone Cement Immucor Inc. H51 Varian Medical Systems.Clin. Exp. English 2749789 Expired OneTouch SureStep Test Strips (lot#274789) were shipped to four Canadian wholesalers.41 (All Builds). Mosaiq 1. could result in uncontrolled patient movement during transfer. C) Version 2. 2009-12-21 2009-11-06 51828 Type II VT465 TECNIS 1-Piece Posterior Chamber IOL Advanced Medical Optics.29. 152737. 31-491 H) 31-509. 09-2010 dating was calculated for the finished device. Lot 544202. A2399 C) A1951 155166 Duralite Pyramid Receiver Prox. There is a potential for the adapter to crack or break while in use by active amputees. 9128 N/A Koordinat M/MP Siemens AG 2009-12-21 2009-08-13 50747 Type III 05294003. 9BD064.50 (All Builds). Cat. 385151 C) 385164 5118921190 A) 8308330 B) A1967. 2009-12-21 2009-11-10 51829 Type II ZCB00 A) Powerhart G3 Automated External Defibrillator B) Powerhart AED G3 Pro C) Powerhart AED G3 Plus D) Powerhart G3 Plus Automatic E) Powerhart . 31520. 31-459. Exp. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient. This may result in the risk of air bubbles leaking into the infusion system through the BD Q-Syte Luer access split septum. 21100-01C(2. 9J2429. 9125. 06239003 Vitrax II (Sodium Hyaluronate) Advanced Medical Optics.00 (All Builds) S067009 Precision and open vial stability issues with this lot may result in increased or decreased APTT times across the range of the assay. >10 Numbers. A) Version 2. 2. Adaptor Sequencer For Mosaiq The Ohio Willow Wood Company Impac Medical Systems Inc. The A) >10 Numbers. Contact Manufacturer I) >10 Numbers.1 & All Previous 9ED058 Customer complaints regarding Dimension Vista Amon method. during patient transfer. Exp. Contact Manufacturer The ground wire of the supply transformer exhibited signs of high resistance in a complaint and may give high eddy currents. 31-513. Precision issues with this lot may result in increased APTT times across the range of the R324001 assay. 9100.5 resulting in a lab investigation. 31-609 C) 31-430. Contact Manufacturer Product may function improperly. 2962490 for EZManager were identified as being blank when used in a computer. Cannot assure sterility or function of the guidewire beyond its expiration date. Contact Manufacturer infectious agents to the patient. 11-2009. 2937776 for EZManager Max CD. 31-528. Contact Manufacturer D) >10 Numbers. it was discovered that a sample tested at the three month time point had a ph value of 7. T1202 Trinity Biotech PLC 2009-12-21 2009-04-23 49895 Type II T1202 Triniclot APTT HS. The current lot #155166 of TG Gen. Contact Manufacturer G) >10 Numbers. Contact Manufacturer H) >10 Numbers. 31-489.The expiration date of the sterile pouched guidewire was not considered when expiration 2010. A) 4230260ppc Review of test records indicated that the seven impacted Powerhart G3 AEDS B) 4226121 manufactured by Cardiac Science Corporation (CSC) may not have received adequate C) 4237595 testing prior to being shipped from the factory.A) BD Q-Syte Extension Set B) MPS Acadia Extension Set With Rightbore C) MPS Acadia Specialty Tri-Extension Set Tg Gen. 1. 31-408. 155488 and 157297 of elecsys thyroglobulin calibrator.1. 31-531 M0064003031 All Lot Numbers Mosaiq 1. Contact Manufacturer F) >10 Numbers. French Compact discs received for EZManager Max Diabetes Management Software packages 2936068. 31-469. 70002A(2.0). Contact Manufacturer The Vitrax II product is being recalled because during routine stability testing.1 & All Previous Incorrect Zimmer implant data in Brainlab Software Knee leads to incorrect information for B) Version 2. >10 Numbers. 31-510.1) C) 70001A. 9120. C) >10 Numbers. Inc. 31-486. 4153329. 22086-03E B) 21100-01(2. Consolidated field sequencing (CFS) feature not working properly as X2 jaw moved when only the X1 jaw should have been moving. 57616. 9H2417. 31-631 D) 31-458. D) 4183220 E) 4218441. 31-685 G) 31-488.60 (Up To. Contact Manufacturer E) >10 Numbers. Brainlab AG 2009-12-21 2009-12-21 2009-09-24 51926 2009-09-11 50954 Type III Type III Part # 010-665 A) 22086-03D.40 (All Builds). This may lead to complications should the air bubbles not be detected. N/A The TECNIS 1-Piece Intraocular Lenses (IOLS) are being recalled because the haptics of some TECNIS 1-Piece IOLS (model ZCB00) have adhered to the lens optic after insertion into the eye. 4153683 A) 2012-06 AA The master carton and the individual dressing packages are labelled correctly. The highest value was found to be 8.1. 31-516. 9H2425. 31-658 E) 31-466. No. 31-519 I) 31-525. 2938247. 2009-12-07 2009-11-02 51661 Type I Roche Diagnostics GMBH 2009-12-07 2009-11-12 51712 Type II A) 385102 B) 385150.5. Inc. catalogue # 90022. 31669 F) 31-485. 57269. The sterile barrier in the packaging (pouch) that contains the catheter may be breached. 9J2437 medium’s expiration date. Decrease of medium selectivity for methicillin-sensitive Saphyloccus aureus strains before 9J2435. 57613 . Siemens has confirmed a negative bias of up to 35% for level 1 quality control when calibrated with Chem 3 Calibrator lot 9ED058 vs. 100-467-50 Animas Corporation 2009-12-21 2009-11-16 51762 Type III OneTouch SureStep Test Strips A) Navigation Software Knee Zimmer B) Brainlab Knee Essential Software C) Brainlab Knee Unlimited Software Dimension Vista System-Chem Calibrators Lifescan Inc. Inc. 31-468. 31-409. 2009-12-07 2009-12-07 2009-11-09 51740 2009-10-16 51821 Type II Type II N/A N/A Triniclot APPT S.2 (Thyroglobulin) Assay Becton Dickinson Infusion Therapy Systems Inc. Lot 545693.AED G3 (Biphasic) A) Tegaderm Hydrocolloid Dressing B) Medipore Soft Cloth Surgical Tape EZManager Max Diabetes Management Software Cardiac Science Corporation 2009-12-21 2009-10-08 51818 Type II 3M Health Care 2009-12-21 2009-11-23 51873 Type III A) 9300A-501PPC B) 9300P-601 C) 9390E-501 D) 9390A-501 E) 9300E-501 A) 90002 B) 2961 100-467-23.2 (Thyroglobulin) Assay shows a premature ageing effect which leads to a positive bias of approximately 1ng/ml TG when used in combination with all current lots # 151605. patient falling to the floor. 1987. Including T2SP4). 31607.1) KC130 Siemens Healthcare Diagnostics Inc. 31-467. Imager II Urology Torque Catheters Boston Scientific Corporation 2009-12-21 2009-11-03 51536 Type II Washer Disinfectors Pronto-Short Extraction Catheter Getinge Disinfection AB Vascular Solutions. Product Code T1204 A) Imager II Angiographic Catheters B) Imager II Catheters BERN C) Imager II Catheters SIM D) Imager II Catheters Contra2 E) Imager II Catheters C F) Imager II Catheters RC G) Imager II Catheters RDC H) Imager II Catheters Pigtail I) Imager II Catheters Contralateral Trinity Biotech PLC Boston Scientific Corporation 2009-12-21 2009-12-21 2009-05-24 49896 2009-11-03 51535 Type II Type II T1204 A) 31-400. 31-602 B) 31-407. 9J2432. Contact Manufacturer breach of sterility could lead to a contamination of the device with subsequent transfer of B) >10 Numbers. the table may unintentionally swivel. Lot 546614. 2009-12-21 2009-12-21 2009-04-23 51707 2009-11-20 51819 Type II Type II 9027. 31-410. The investigation revealed that some units from different lots post ETO sterilization have a ph greater than the upper ph limit of 7. Max CD.1. 9H2414. Mosaiq 1. 57271.1 & All Previous Zimmer Innex implants. 05. This situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.8 to 7. 2009-12-21 2009-10-19 51373 Type III Siregraph CF MRSASelect Referance 63747 Coffret 20 Plaque Siemens AG Bio-Rad 2009-12-21 2009-12-21 2009-10-08 51376 2009-10-23 51525 Type III Type II 04 98 717 63747 The sterile barrier in the packaging (pouch) that contains the catheter may be breached. 31-402. however the B) 2012-10 XT boxes that contain the individual dressing packages were labelled for Tegaderm Hydrocolloid thin dressing.70 which exceeded the ph specification range of 6. Contact Manufacturer If the swivel locking mechanism is not completely engaged into position. >10 Numbers. The manufacturer has determined that customers should not use it for this purpose anymore. 3089 The potential hazard of fingers or hands getting caught exists when the patient holds on to the tomographic rod between the column/tube assembly and the spotfilm device. The lot is not stable for the full 30 day period when opened and stored. Contact Manufacturer >10 Numbers. i-CAT classic units containing mechanical brake or containing dual brake system. thus the medio-lateral cuts are too large compared to the Talar trial implant dimensions. Fault in the brake system may result in gantry-overhead dropping quickly when the overhead is lowered. crack or separate. 2009-12-21 2009-09-07 51309 Type III IW910. 58535112. The instrument may generate a negative well interpretation for capture-R ready-screen or capture-R ready-ID assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal). an issue has been confirmed for QC isolates when tested on the walkaway instrument. Contact Manufacturer ICU070488. 58496258. A09-012.1x50mm 3. 2008 are misprinted on the right side of the box flap. Blue connector proximal to Tuohy-Borst hemostasis valve may fatigue. 4203. part number 01-7141 were packaged and distributed without the instructions for use. The kit is intended for use with urine samples not blood or plasma. 2246. The width of the defective Talar Cutting Guides is too large. IW934. across the same electrode pair. Contact Manufacturer Galileo Echo Blood Bank Analyzer Immucor Inc.01 Panel Update-01 Becton Dickinson Canada Inc. 3. BD has determined that a small number of unit packages may have open seals which can adversely impact product package integrity/product sterility. This could result in having cotton fibres remaining within the urethra during specimen collection of male patients.fault in brake system may result in the gantry-overhead carriage moving below its limits. Inc. i-CAT classic containing electrical brake. Berlin Heart GMBH Toshiba Medical Systems Corporation Imaging Sciences International. Inc. 58606253. Contact Manufacturer K13333.01 Dade Hepzyme (B4240-10) Siemens Healthcare Diagnostics Products GMBH 2009-12-21 2009-12-02 51994 Type III B4240-10 528752 IW900 Series Infant Warmer Fisher And Paykel Healthcare Ltd. 536306. resulting in patency failure & potential blood loss where Intro-Flex Introducer secures a venous catheter. Contact Manufacturer B) 58511631. dubliniensis potentially leading to false ID of isolate. In ultrasound systems using the Ultrasound Convex Transducer PVT-681MV. Siemens Healthcare Diagnostics received customer complaints regarding QC isolates when tested on the walkaway instrument. PN 94400. S5507BF85 A) N/A B) N/A Cyberonics Inc.Rapid Eric Electronic Compendium Excor System-Connecting Set For Cannula Diagnostic Ultrasound Transducers / Probe i-CAT 3D Dental Imaging System Twist Drill 1. Biosite. Error 103 (karel e-stop detected) and error 342 (deviation in absolute position value DSE . A12-016 PVT-681MV 9140-0000-0000 01-7141 FG540000 1096277 526337 >10 Numbers. Biosite Incorporated 2009-12-21 2009-12-21 2009-10-30 51944 2009-05-28 50030 Type II Type III 9140-0000-0000 94400 >10 Numbers. If RF energy and pacing stimuli are delivered simultaneously. Inc. Also trading as: Biomet Microfixation Biosense Webster (Israel) Ltd. initiates notice of correction for Triage Tox Drug Screen Kit. Enhanced labelling to prevent end of service (EOS) warning messages & reduced battery life resulting from electromagnetic induction (EMI). 58549300. a DC voltage may be generated. 2009-12-21 2009-11-25 51956 Type II 87000 N/A Hintegra Talar Cutting Guides Amplicor STD Specimen & Transport Kit New Deal SA Roche Molecular Systems. This issue only applies to those that have installed the LP V3. It was observed that a too short cut of the adapter cannula combined together with certain conditions of stress may have a effect of leakage of the cannula. 2036 BD 30ml Luer-Lok Syringes LabPro V3.01 panel update 01 and utilization of the panel type POS combo 33 (PC33). This can cause micro-bubbles in the blood within the heart chamber.5mm stop with J notch. the volume image acquired in 'plane C' is reversed horizontally. Potential for the male swab to present a defectiveness where the cotton head of the swab may dislodge and/or unravel with minimal force. Three manufacturing lots of Twist Drill 1. electrostatic discharge (ESD). 2009-12-21 2009-12-03 52025 Type II A) >10 Numbers. Inc. The misprint incorrectly states "use EDTA whole blood or plasma sample only". 58604814. including the Carto 3 system. Biosense Webster. albicans from C. 58648812. Inc. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Boxes shipped after August 6. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals. IW932. 58644423 A) All Lot Numbers B) All Lot Numbers Error limited to the Rapid Yeast Plus Database regarding differentiation of C. ICU070518. Inc. K15492. 2009-12-21 2009-06-22 50252 Type II 28000 C202 A) Intro-Flex Introducer Sets B) Percutaneous Sheath Introducer Kit A) VNS Therapy Demipulse Programmable Generator B) VNS Therapy Demipulse Duo Generator Edwards Lifesciences LLC 2009-12-21 2009-05-21 48857 Type II A) 1350BF85 B) I652BF85H. Following the installation of LabPro 3. WITH SUFFIX JEU All Infant Warmers in Canada. QC issue affects combo type panels. IW920. 535933 3257. K15491. Customer complaints regarding incorrect high APTT values that may be observed on heparin and heparin-free samples treated with lot 528752 of Dade Hepzyme when using lot 528752 of Dade Hepzyme with non-Siemens APTT reagents. 4184 i-CAT 3D Dental Imaging System Triage Tox Drug Screen PN 94400 Imaging Sciences International. Walter Lorenz Surgical. Notifying users in Canada of updating cleaning instructions for the IW900 series infant radiant warmers.1 x 50mm.RDC) were displayed. IW930. K13334. has recently become aware of a potential hazard that may occur during the operation of the bloom DTU-215b cardiac stimulator (not a Johnson & Johnson device) in conjunction with RF generators and EP equipment. CyberKnife Robotic Radiosurgery System Accuray. 2009-12-21 2009-12-21 2009-10-20 51435 2009-11-27 51858 Type II Type II Left Cutting Guide. ICU070519 537407.01 panel update-01 (9800-3768 compact disk). Inc. IW980. Siemens Healthcare Diagnostics Inc. 2009-12-21 2009-12-21 2009-12-21 2009-12-21 2009-12-21 2009-12-21 2009-10-30 51669 2009-10-02 51703 2009-10-30 51870 2009-10-30 51709 2009-11-18 51857 2009-11-25 51915 Type I Type I Type II Type II Type III Type II RE8323600 A06-009. or electro cautery exposure during surgery. IW950.5mm stop Carto 3 EP Mapping System Remel Inc. Right Cutting Guide 20753920122 >10 Numbers. A healthcare facility reported their end-to-end targeting accuracy was out of specification. 2009-12-21 2009-12-21 2009-11-26 51921 2009-11-30 51937 Type II Type III 309650 9800-3771 9175046 Software Version 3. 4166. .