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: 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: 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: 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: 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: 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 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

Company: Respironics California IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04. CODE All codes. RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. REASON Ventilator would spontaneously suspend ventilatory support to...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON Software coding error may cause a fatal error message. CODE All software versions prior to version 1.4. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated...Read More

Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...Read More

Company: Hudson Respiratory Care Inc.Date of Enforcement Report: 5/12/04 Class: II PRODUCT Concha IV Plus Heated Humidifier. Recall # Z-0929-04. REASON Software malfunction. CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA , by visit...Read More

Medical Device RecallsClass 1 Recall: Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation Date Recall Initiated: May 5, 2004 Product: COBAS GUI Software Interface between the Tecan Clinical Workstation and the COBAS Amplicor Analyzer. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and...Read More

Date Recall Initiated: May 5, 2004 Product: Tecan Clinical Workstation configured with the Roche Diagnostics Amplicor CT/NG Analyzer Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea. Recalling Firm: Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025 Reason for Recall: A software error...Read More

Medical Device RecallsClass 1 Recall: Tecan Clinical Workstation with RoboNet Software Date Recall Initiated: May 3, 2004 Product: Tecan Clinical Workstation configured with the RoboNet Software. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia, gonorrhea and other tests. An operator controls the Tecan Clinical Workstation...Read More

Company: Gyrus Medical, IncDate of Enforcement Report: 4/28/04 Class: II PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON The generator may malfunction when used in close proximity to a monopolar generator. CODE Model 744000....Read More

Company: Abbott Laboratories, Inc.Date of Enforcement Report: 4/28/04 Class: II PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71- 04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON When using a LIS the software system will send up a test result of up to 20 characters although...Read More

Company: Spencer Technologies, Inc.Date of Enforcement Report: 4/21/04 Class: II PRODUCT Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software – the change from TCD 100M to PMD 100 is a marketing change)....Read More

Company: Medex, Inc.Date of Enforcement Report: 4/21/04 Class: III PRODUCT Medex 3000 Series Syringe Infusion Pumps. Recall # Z-0813-04. CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump...Read More

Company: Instrumentation Laboratory CoDate of Enforcement Report: 3/31/04 Class: II PRODUCT a) ACL Futura Instrument Analyzer. Recall # Z-0736-04; b) ACL Advance Instrument Analyzer. Recall # Z-0737-04. REASON Software may cause instrument to omit step causing reagent carryover which may effect patient test result. CODE a) Software prior to Version V3-5; b) Software version prior...Read More

Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 3/31/04 Class: II PRODUCT PatientNet Monitoring System – PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04. REASON Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. CODE All PatientNet Central Stations. RECALLING FIRM/MANUFACTURER General...Read More

Company: Siemans Medial Solutions USA, Inc CoDate of Enforcement Report: 3/31/04 Class: III PRODUCT Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04. REASON Software problem – mode does not appear on screen. CODE Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292. RECALLING FIRM/MANUFACTURER Siemans Medial Solutions USA, Inc, Plymouth Meeting,...Read More

Company: Coherent Inc Laser GroupsDate of Enforcement Report: 3/24/04 Class: I PRODUCT Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04. REASON Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated. CODE Serial Numbers/Model Numbers: TFAP0004P-TFAP00048. RECALLING FIRM/MANUFACTURER Coherent Inc...Read More

Company: Beckman Coulter IncDate of Enforcement Report: 3/24/04 Class: II PRODUCT a) CXP software, Part No. 623560. Recall # Z-0635-04; b) Cytomics MXP Software, Part No. 623688. Recall # Z-036-04; c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261, 175262, 175263, 175264, 175265. Recall # Z-0637-04. REASON Software anomaly. Sample ID and the Run...Read More

Company:Toshiba American Med SysDate of Enforcement Report: 3/10/04 Class: III PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON Software anomally causes image slices to be in incorrect order. CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to...Read More

Company: Varian Medical SystemsDate of Enforcement Report: 3/10/04 Class: II PRODUCT EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04. REASON Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy CODE Serial numbers (Domestic units): 724 215 765 210 212...Read More

Company: Soft Computer Consultants, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT “Softbank II” Laboratory Information System. Recall # B-0841-4. REASON Defects in the design of blood bank software program could result in incorrect patient laboratory records. CODE V.19, V.21, and V.22; Release 3.1.3. RECALLING FIRM/MANUFACTURER Soft Computer Consultants, Inc., Palm Harbor, FL, by telephone...Read More

Company: Coherent, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04. REASON Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser CODE None. RECALLING FIRM/MANUFACTURER Coherent, Inc, Santa Clara, CA, by technician visit to install software,...Read More

Company: GVI Technology PartnerDate of Enforcement Report: 2/18/04 Class: III PRODUCT CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04. REASON Due to limitations in the operating software, the acquired scan may not be processed properly. CODE S/Ns: 100 thru 105, and 107 thru 116. RECALLING FIRM/MANUFACTURER GVI...Read More

Company: Medtronic MiniMedDate of Enforcement Report: 2/18/04 Class: III PRODUCT Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04. REASON A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. CODE All...Read More