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: 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: 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: 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

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: Cerner CorporationDate of Enforcement Report: 2/11/04 Class: II PRODUCT Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306. Recall # B-0440-4. REASON Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was...Read More

Company: Medtronic MiniMedDate of Enforcement Report: 1/21/04 Class: III PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON Accessory software fails to report certain reports following download of data from 712 pump. CODE Version 5.0A. RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on...Read More

Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 1/21/04 Class: II PRODUCT Solar 9500 Information Monitor. Recall # Z-0250-04. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. CODE Software version 3A. RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee,...Read More

Company: Misys Healthcare Systems.Date of Enforcement Report: 1/21/04 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile...Read More

Company: Urologix, Inc., Date of Enforcement Report: 1/21/04 Class: II PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report: 1/21/04 Class: II PRODUCT a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...Read More

Company:Minolta Corp.Date of Enforcement Report: 1/14/04 Class: II PRODUCT a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger,...Read More

Company: Information Data ManagementDate of Enforcement Report: 1/9/04 DATE RECALL INITIATED: January 9, 2004 PRODUCT / VERSIONS: IDM Surround System, Software versions 3.4, 3.5, and 3.6 REASON: IDM’s Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 12/24/03 Class: II PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and...Read More

Company: Varian Brachytherary VirginiaDate of Enforcement Report: 12/17/03 Class: II PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04. REASON The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0151-04. REASON Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. CODE Versions 5.2, 5.23, 5.3 up to...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: I PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0007-04. REASON Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile on August...Read More

Company: Biotronik, Inc.Date of Enforcement Report: 11/26/03 Class: II PRODUCT a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0076-04; b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0077-04. REASON Potential for early depletion of Implantable Cardioverter Defibrillator battery. CODE a) Serial Numbers: 7811xxxx;...Read More

Company: General Electric Medical Systems Information Technology,Date of Enforcement Report: 11/19/03 Class: II PRODUCT Solar 8000M Patient Monitor. Recall # Z-0092-04. REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display,...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/19/03 Class: II PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04. REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. CODE Version 1.02ER000 and...Read More

Company: Veterans Health Administration Office of InformationDate of Enforcement Report: 11/19/03 Class: II PRODUCT VistA Blood Bank Software. Recall # B-0301-4. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version number 5.2, software patch LR*5.2*301. RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines,...Read More

Company: Bayer Corp.Date of Enforcement Report: 11/5/03 Class: II PRODUCT Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04. REASON Potential for bias shift in p02 values due to air bubble in sample path. CODE Software Versions below 3.1. RECALLING FIRM/MANUFACTURER Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 10/22/03 Class: II PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04. REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted. CODE All units with current software...Read More

Company: Olympus America Inc.Date of Enforcement Report: 10/22/03 Class: II PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04. REASON Software malfunction; potential for simultaneous cross-linking of...Read More

Company: DPC CirrusDate of Enforcement Report: 10/15/03 Class: III PRODUCT Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03. REASON Version 2.6 software was released however, it will not properly handle adjustment slopes. CODE All units. RECALLING FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ, by Recall Technical...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 10/8/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1240-03. REASON Software Defect. CODE Verison 5.3 through 5.3.2. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 466. DISTRIBUTION Nationwide.Read More

Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M CODE Units with software versions A.02.00 or greater. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing. REASON Instructions for use include additional information on configuration...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03; b) Gyroscan NT-Intera. Recall # Z-1228-03; c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03. REASON Patient burns from cables near or in contact with the patient during use. CODE a) 6808,...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1217-03. REASON Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. CODE Version 5.2 through 5.3.2 using LabAccess Results. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on...Read More

Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...Read More

Company: Philips Medical Systems.Date of Enforcement Report: 9/17/03 Class: II PRODUCT Easy Access PACS System with software. Recall # Z-471-3. REASON Potential display of an incorrect body part description on patient images. CODE Software Release 5, 6.2, or 7.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03. REASON Software Design Defect. Under certain conditions, results are removed. CODE Version 3.x. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: ABX Diagnostics, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03. REASON Instrument fails to obtain correct patient information/results due to malfunction of the equipment’s sample door. CODE Software versions of up to 1.7. RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA, by letter on June 5,...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03. CODE Software version 3.29. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing. REASON Defective software media distributed with...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 9/10/03 Class: II PRODUCT Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03. REASON ICT assays run using a manual dilution will not be calculated correctly by the software. CODE All units. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall...Read More

Company: Olympus America, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT Olympus Image Manager Software. Recall # Z-1126-03. REASON Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. CODE Versions 6.0 through 6.4. RECALLING FIRM/MANUFACTURER Olympus America, Inc., Melville, NY, by letters, dated...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/27/03 Class: II PRODUCT Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03. REASON Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment. CODE Versions 5.3 up to...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT a) MR Systems. Recall # Z-1087-03; b) Leonardo Workstations with software version 2022A/B, 2003A. Recall # Z-1088-03; c) Leonardo Workstations with software versions prior to 2022A. Recall # Z-1089-03. REASON Software problem. This error may cause the loss of peripheral image information...Read More

Company: Alcon Laboratories, IncDate of Enforcement Report: 8/20/03 Class: II PRODUCT “Alcon Ladarwave Custom Cornea Wavefront System” Aberrometer software Version 7.91. Recall # Z-1078-03. REASON Software error could, under specific circumstances, allow the patient’s centration images and data to be stored incorrectly. CODE Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1092-03. REASON Patient files become mixed up due to a software defect. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare System, Tucson, AZ, by fax on July 2, 2003. Firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 1....Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1090-03. REASON Software anomaly allows patient reports to contain incomplete data used for Anatomic Pathology Module. CODE Version 5.3 and up to 5.3.2 with Anatomic Pathology Module. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on June 16,...Read More

Company: Roche Diagnostics, CorpDate of Enforcement Report: 8/6/03 Class: II PRODUCT MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03. REASON A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols. CODE All systems using software version 3.0. RECALLING FIRM/MANUFACTURER Roche...Read More

Company: Medex, IncDate of Enforcement Report: 8/6/03 Class: II PRODUCT Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea, (the pumps with different languages have different...Read More

Company: Abbott Laboratories HPD/ADDDate of Enforcement Report: 8/6/03 Class: II PRODUCT AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03. REASON AFP results obtained when using the 1:101 automated dilution protocol showed an...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 7/30/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1007-03. REASON Software anomally. Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal disignations. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax...Read More

Company: Roche Diagnostics, CorpDate of Enforcement Report: 7/30/03 Class: II PRODUCT MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03. REASON Potential for false negative patient results with software version 3.0. CODE All units with software version 3.0. RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/30/03 Class: II PRODUCT Magic View 1000U, version VE40A. Digital Image Communication System. Recall # Z-1029-03. REASON Software issue. New examinations may not be saved properly and the examination may be lost. CODE Part number 7502003. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA, by...Read More