Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05. REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program...Read More

Company: Cincinnati Sub-Zero ProductsDate of Enforcement Report: 4/13/05 Class: II PRODUCT Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05. REASON There is the potential that the power switch assembly can dislodge from the cabinet during use. CODE All units containing version 0.70 software. RECALLING FIRM/MANUFACTURER Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated...Read More

Company: Philips Medical Systems Sales and Service Region No. Americ.Date of Enforcement Report: 3/30/05 Class: II PRODUCT Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05. REASON Loss of image data from image repository and archive requiring patients to undergo repeat imaging. CODE Xcelera Software version R1.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems...Read More

Company: Heartsine Technologies, IncDate of Enforcement Report: 3/30/05 Class: I PRODUCT Heartsine Samaritan AED Defibrillators — Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05. REASON The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow...Read More

Company: Cardiac Science, Inc.Date of Enforcement Report: 2/16/05 Class: II PRODUCT a) Powerheart AED G3 Automated External Defibrillator Model 9300E. Recall # Z-0398-05; b) Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Recall # Z-0399-05. REASON AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this...Read More

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05. REASON A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being...Read More

Company: Baxter Healthcare Renal DivisionDate of Enforcement Report: 2/9/05 Class: II PRODUCT HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05. REASON A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products. CODE Units with software version 8.7 used with Physioneal...Read More

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05. REASON Logix-CM software version 3.0.4 has not completed its official release process. CODE Software version 3.0.4. RECALLING FIRM/MANUFACTURER Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing. VOLUME OF...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 1/12/05 Class: II PRODUCT Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05. REASON In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy. CODE...Read More

Company: Dade Behring, IncDate of Enforcement Report: 1/12/05 Class: II PRODUCT StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05. REASON Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems. CODE Software version 3.5. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letters dated November 12,...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report: 1/12/05 Class: II PRODUCT a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05; c)...Read More

Company:Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05. REASON Software defect causes images to be rotated 180 degrees. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc., Tustin,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 12/22/04 Class: II PRODUCT MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05. REASON Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09. CODE All systems using software version 3.09. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp.,...Read More

Company: Coherent, InccDate of Enforcement Report: 12/22/04 Class: II PRODUCT Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0360-05. REASON Software problem that may cause unintended emission of laser radiation. CODE All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092....Read More

Company: Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05. REASON Software defect causes patient identification number to be truncated. CODE No specific codes were listed. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc, Tustin,...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT DL2000 Data Manager Software, Version 6.4.108. Recall # Z-0267-05. REASON Possibility of reporting an incorrect result occurs due to a software anomally. CODE Version 6.4.108. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on November 5, 2004. Firm initiated recall is ongoing. VOLUME...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05. REASON A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: III PRODUCT CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05. REASON Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect. CODE Versions 1.0, 1.1, and 2.0. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter of...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 11/10/04 Class: II PRODUCT Pagewriter Touch Cardiograph Software. Recall # Z-0063-05. REASON Software can generate printed ECG’s that associate incorrect patient data with the waveform. CODE Software Versions A.01.01 or A.01.02. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is...Read More

Company: Medical Industries America, Inc.Date of Enforcement Report: 11/10/04 Class: II PRODUCT Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 – Consisting...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/3/04 Class: II PRODUCT a) AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Recall # Z-0032-05. b) AXIOM Sensis Programmable diagnostic comp uter, Model number 66 34 633. Recall # Z-0033-05; c) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641. Recall #...Read More

Company: Datascope CorpDate of Enforcement Report: 10/20/04 Class: II PRODUCT Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-0018-05. REASON Software anomaly where the variable heart rates may be displayed inaccurately or intermittent “dashes” may be displayed when the patient’s heart rate is derived from ECG. CODE Serial Number: MC02017-I3; MC02134-I3; MC02138-I3;...Read More

Company: Medtronic IncDate of Enforcement Report: 9/29/04 Class: I PRODUCT 8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N’Vision Clinician Program. Recall # Z-1334-04. REASON Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the...Read More

Company: Siemens Medical Solutions USA, Inc..Date of Enforcement Report: 9/22/04 Class: II PRODUCT Axiom Sensis Report Workstation. Recall # Z-1446-04. REASON Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab. CODE Serial Numbers 1002, 1034, 1100-1253, 1300-1504. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report: 9/15/04 Class: II PRODUCT a) Roche/Hitachi 747 – 100 clinical chemistry analyzer; catalog number 04009223680. Recall # Z-1428-04; b) Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001. Recall # Z-1429-04; c) Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160. Recall #...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 9/15/04 Class: II PRODUCT MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-1371-04. REASON A hardware/software problem will result in low elution volumes and bias sample results for various protocols. CODE All units using software version 3.03. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp, Indianapolis, IN, by...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/15/04 Class: II PRODUCT COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also...Read More

Company: Varian Medical Systems, Inc.Date of Enforcement Report: 9/1/04 Class: II PRODUCT Varian Mdical device and software systems. Version Numbers 6.2.27 and 6.2.35, 510k number K001643. Recall # Z-1314-04. REASON A malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters...Read More

Company: The Contact Lens Store, Inc.Date of Enforcement Report: 9/1/04 Class: II PRODUCT Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee,...Read More

Company: Daavlin Distributing Co.Date of Enforcement Report: 8/25/04 Class: II PRODUCT a) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #PASNBSM-2424. Recall # Z-1233-04; b) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ASNBSM-2424. Recall # Z-1234-04; c) 3 Series Full Body Phototherapy Device with Smart Touch...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 8/4/04 Class: III PRODUCT DataLink 2000 Data Manager. Version 6.3. Recall # Z-1096-04. REASON Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system. CODE Version 6.3 RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter on November 3,...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 7/28/04 Class: II PRODUCT Synchron Systems Lipid Calibrator (HDLD) Part Number: 650218. Recall # Z-1153-04. REASON Incorrect units are printed in labeling but not in software. CODE Kit: M302210 Level 1; M302211 Level 2; M302212. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on October 8, 2003....Read More

Company: Medtronic IncDate of Enforcement Report: 7/28/04 Class: II PRODUCT a) Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 701 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also by...Read More

Company: Adac LabsDate of Enforcement Report: 7/21/04 Class: III PRODUCT Emission Computed Tomography System. Recall # Z-1079-04. REASON Software problems may cause the detector head to drift unexpectedly. CODE Model number 2163-3000A, 2163-3000B; 510K K011611. RECALLING FIRM/MANUFACTURER Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company: Fischer Imaging CorpDate of Enforcement Report: 7/21/04 Class: II PRODUCT Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04. REASON Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. CODE Product number 94829G-1, 94830G-1, 94830G-2. RECALLING FIRM/MANUFACTURER Fischer Imaging Corp, Denver, CO, by...Read More

Company: Siemens Medical Solutions USADate of Enforcement Report: 7/21/04 Class: II PRODUCT Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04. REASON The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR...Read More

Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Linear accelerator workstation software suite. Recall # Z-1084-04. REASON An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1. CODE MLC Workstation...Read More

Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04. REASON Audio alarm may fail to sound when Sp02 limits drop below the set limits. CODE Software versions 2.0 or 2.5. RECALLING FIRM/MANUFACTURER Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002...Read More

Company: Sechrist Industries, Inc.Date of Enforcement Report: 6/30/04 Class: II PRODUCT Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. Recall # Z-1032-04. REASON Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all. CODE Ventilators with production serial numbers beginning with a...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 6/23/04 Class: I PRODUCT COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall # Z-1021-04. REASON The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong...Read More

Company: CAS Medical Systems, Inc.Date of Enforcement Report: 6/23/04 Class: II PRODUCT Cardio Respiratory Monitor with Oximax technology with software version 5.0, Model 511. Recall # Z-1023-04. REASON Device may not alarm for %SpO2 value limit violations if a specific feature is enabled. CODE Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through...Read More

Company: Radionics, Inc Date of Enforcement Report: 6/23/04 Class: II PRODUCT Radionics Head and Neck Localizer (HNL), Version B. Recall # Z-1020-04. REASON Software may provide inaccurate coordinates and cause mistreatment. CODE Serial Numbers: 032610023, 0326100023, 32690010, 041200023. RECALLING FIRM/MANUFACTURER Radionics, Inc., Burlington, MA, by telephone and letters dated May 25, 2004. Firm initiated recall...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 6/23/04 Class: II PRODUCT DL 2000 Data Manager. Recall # Z-1027-04. REASON Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream. CODE Version 6.2. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on February 14,...Read More

Company: Hitachi Medical Systems America IncDate of Enforcement Report: 6/16/04 Class: II PRODUCT Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04. REASON Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result...Read More

Company: Baxter Healthcare Renal DivDate of Enforcement Report: 6/16/04 Class: II PRODUCT a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04; b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013- 04. REASON A software...Read More

Company: Fujifilm Medical System USA, IncDate of Enforcement Report: 6/9/04 Class: III PRODUCT Fuji Flash IIP and CR-IR346CL Consoles. Recall # Z-0993-04. REASON Software: Incorrect measurement of objects within a CR image. CODE Versions A09-17 through A11-12. RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated May 5, 2004. Firm initiated recall...Read More

Company: Philips Medical Systems Sales & Service Region No. AmericaDate of Enforcement Report: 6/2/04 Class: II PRODUCT Xcelera System, image processing, radiological. Recall # Z-0973-04. REASON Potential for the image data to be erased from the long term archive. CODE Part numbers: 9896 050 73251XC1.1L1, Software binder: 9896 050 73252XC1.1L1 Software binder + SP2. RECALLING...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/19/04 Class: II PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample...Read More

Company: ADAC Laboratories, MadisonDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System,...Read More

Company: Baxter Healthcare Renal DivDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to...Read More