Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory System Version 5.3. Recall # Z-0670-03. REASON Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03. REASON Software anomally. Graphical display omits results containing a less than () or percent (%) symbol. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003....Read More

Company:Beckman Coulter, IncDate of Enforcement Report: 4/9/03 Class: III PRODUCT LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03. CODE REASON Incorrect Hemoglobin result can be reported at software version 2A and higher. All instruments with version 2A or higher. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by telephone and letters...Read More

Company: Varian Medical Systems, IncDate of Enforcement Report: 3/26/03 Class: II PRODUCT VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03. REASON The product has a software problem. This could result in a treatment without a motorized wedge where one had...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0614-03. CODE Versions 5.2, 5.23 and 5.3. REASON Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0626-03. REASON Software anomaly. Patient results may be filed in the incorrect patient file. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing. VOLUME...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0647-03. REASON Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface. CODE Version 5.3 with Reference Laboratory Interface. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm...Read More

Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 3/12/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0581-3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. CODE Version 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...Read More

Company: Baxter Healthcare, Corp..Date of Enforcement Report: 3/5/03 Class: III PRODUCT a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03; b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-0565-03. REASON Potential for low ultrafiltrate volumes...Read More

Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 1/29/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0455-3. CODE Version 5.2, 5.23, and 5.3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 1/15/2003 Class: III PRODUCT EXPO 32 Software. Recall # Z-0407-3. REASON Software contains errors that might affect Cytometry instruments. CODE Versions 1.0, 1.1B, and 1.2. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 1/8/2003 Class: II PRODUCT AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3. The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVTSystem, Tomography, Computed, Emission,...Read More

Company: Baxter Healthcare CorpDate of Enforcement Report: 12/25/02 Class: II PRODUCT HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3. The following models are affected: a) Baxter HomeChoice Automated PD System, catalog 5C4471, 115 volt; b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt; c) Yume Automated PD System,...Read More

Company: Mediware Information Systems, IncDate of Enforcement Report: 12/18/02 Class: III PRODUCT Hemacare Blood Bank Data Management System, Recall # B-0301-3 REASON Blood bank computer software, which had a defect that could cause antigen test results to be associated with the wrong unit or sample, was distributed. CODE Version 5.2b(b). RECALLING FIRM/MANUFACTURER Mediware Information Systems,...Read More

Company: Hamilton CompanyDate of Enforcement Report: 11/13/02 Class: II PRODUCT a) Hamilton Brand Sunrise Software – for the Microlab AT series Instruments; b) Hamilton Brand Sunplus Software – for the Microlab AT Plus and AT Plus 2 series Instruments; Recall # B-0115-3. REASON Automated pipette software, which had a glitch or defect, was distributed. CODE...Read More

Company:Beckman Coulter, IncDate of Enforcement Report: 11/6/02 Class: II PRODUCT Synchron LX 20, Part # 466101; Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3. REASON Low results on the cartridge chemistry assays, syringe valve seat issue. CODE All units with software version 2.1 are affected. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 10/30/02 Class: III PRODUCT Access 2 Immunoassay Systems — Systems Software Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3. REASON Erroneous result flags can result on printed reports and screen displays in rare circumstances. CODE Product Name: Access 2 Software Part Number: 973074 Lot Number Software Version...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/23/02 Class: III PRODUCT Somatom Sensation 16 systems. Software upgrade from Somaris/5 VA50A to VA50B. Recall # Z-0109-3. REASON Scans may be aborted if scans are started manually. CODE Model Number 7393114. Four serial numbers 50012, 50022, 50025, 50029. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc.,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 10/16/02 Class: II PRODUCT Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3. REASON Possibile incorrect breast cancer marker results. CODE Serial numbers 1058-11, 1164-70 and 0806-10. (All analyzers with software version 06-01.) RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8,...Read More

Company: Spacelabs Medical, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Recall # Z-1395-2/Z-1401-2. a) Telemetry Digital Processors Models 90342, 90344, 90346, 90348. Recall # Z-1395-2/Z-1398-2; b) Integrated Multiparameter Module Model 90470. Recall # Z-1399-2; c) Telemetry Receiver Module Model 90478. Recall # Z-1400-2; d) Ultarview Command Module Model 90496. Recall # Z-1401-2. REASON ECG...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Cytomics RXP software. Recall # Z-1387-2. REASON When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected. CODE Version 1.0. RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA, by letters dated May 15,...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys Laboratory. Recall # Z-0002-3. REASON Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2. REASON Software anomaly causing mixing of patient data. CODE Version 5.3 with custom Result Interface 11. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1377-2. REASON Software anomaly. Footnotes are incomplete and do not print on reports. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1378-2. REASON Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved. CODE Versions 5.2, 5.23, 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.Firm initiated recall is...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Aeroset Software Version 1.01ER000. Recall # Z-1352-2. REASON Sample results may be skewed by failure to properly ‘blank’ the sample. CODE Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by telephone...Read More

Company: Medical Data Electronics, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Defibrillator/ Pacer Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2. REASON Intermittent operation of the paddles. CODE Serial Numbers 10392 thru 10540. RECALLING FIRM/MANUFACTURER Recalling Firm: Medical Data...Read More

Company: Becton Dickinson Microbiology SystemsDate of Enforcement Report: 9/25/02 Class: II PRODUCT Becton Dickinson’s EpiCenter Data Management System software. Recall # Z-1338-2. REASON IVD software defect may cause incorrect patient results to be reported. CODE EpiCenter Software, version 3.20B, Catalog #441007. RECALLING FIRM/MANUFACTURER Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002....Read More

Company: Mysis Healthcare Systems, IncDate of Enforcement Report: 9/18/02 Class: II PRODUCT Misys Commercial Laboratory. Recall # Z-1318-2. REASON Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in...Read More

Company: Mysis Healthcare Systems, Inc.Date of Enforcement Report: 9/18/02 Class: II PRODUCT Mysis Commercial Laboratory. Recall # Z-1285-2. REASON Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR). CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a. RECALLING FIRM/MANUFACTURER...Read More

Company: Misys Healthcare Systems IncDate or Enforcement Report: 9/18/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1281-2. REASON Software anomaly regarding cell counts. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ, by fax on April 23, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 469. DISTRIBUTION...Read More

Company: Roch DiagnosticsProduct: Accu Check Inform Blood Glucose System Class II Date of Enforcement Report: 8/28/2002 All units that have ever displayed a temperature icon in conjunction with patient use. Reason: May give erroneous results if the temperature icon has ever been displayed with use. Manufacturer: Roch Diagnostics, Mannheim, Germany. Recalled by: Roche Diagnostics Corporation,...Read More

Company: Diasorin IncDate of Enforcement Report: 8/28/02 Class: II PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma. Recall # Z-1265-2. REASON As a result of a software error,...Read More

Company: Bayer CorporationDate of Enforcement Report: 8/21/02 Class: III PRODUCT Brand Name: ADVIA Centaur(R) Analyzer. Recall # Z-1233-2. REASON Software programming error. CODE All serial numbers distributed with Model/Part Number 572561, along with all existing software versions from 2.1 to 2.5. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by letter on...Read More

Company: Dade Behring, IncDate of Enforcement Report: 8/21/02 Class: II PRODUCT Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry Analyzer). Recall # Z-1226-2. REASON The sample probe does not accurately track the fluid level. CODE Xpand software revision 6.0.1 and 6.1. RECALLING FIRM/MANUFACTURER Recalling Firm: Dade Behring, Inc., Newark, DE, by telephone on May...Read More

Company: Baxter Healthcare CorpDate of Enforcement Report: 8/14/02 Class: I PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. REASON Software allows ingredient concentration errors during compounding. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: Siemens Medical Solutions USADate of Enforcemet Report: 8/14/02 Class: I PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. REASON Incorrect image time stored for static images resulting in incorrect results. CODE e.soft software version 2.0 installed...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 8/7/02 Class: II PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure...Read More

Company: Philips Medical Systems Date of Enforcement Report: 7/31/02 Class: II PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2. REASON Higher than...Read More

Company: Baxter Healthcare CorpDate of Enforcement Report: 7/31/02 Class: II PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. REASON Software anomaly allows access to change prescription or program bolus without security. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER...Read More

Company: Semens Medical SystemsDate of Enforcement Report: 7/31/02 Class: II PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology. Recall # Z-1162-2. REASON Software anomalies that affect measurement and calculation data. CODE...Read More

Company: Varian Medical Systems, Inc Date of Enforcement Report: 7/3/2002 Class: II PRODUCT Varian Medical System’s Eclipse VERSION 6.5 software, a proprietary application for Varian Vision ™ imaging systems. Recall # Z-1109-2. REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen. CODE Eclipse software, version 6.5, Serial Numbers: 0016 0018 0022 0034...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 7/3/2002 Class: II PRODUCT Information Center System and Upgrades as follows: a) M3150A Agilent or Virida Information center. Recall # Z-1119-2; b) M3151A Agilent or Virida Information Center Client. Recall # Z-1120-2; c) M3153A Agilent or Virida Surveillance Center. Recall # Z-1121-2; d) M3150AU#A01 Agilent or Virida Information...Read More

Company: Toshiba America Medical Systems, IncDate of Enforcement Report: 6/26/02 Class: II PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2. REASON Software anomally caused error in calculating VM_P. CODE Serial Numbers: B1552349 C1572413 C1572414 C1572415 C1572417 C1572418 C1572420 C1572423 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572421. RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,...Read More

Company: Advanced Sterilization ProductsDate: 6/19/2002 Class: II PRODUCT STERRAD 100S Sterilization System. Recall # Z-1082-2. REASON Software anomaly allows half cycle run when full cycle displayed. CODE Version 3 or lower is subject to upgrade. Newer versions contain software “fix”. Current version is Version 6. RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA, by letters sent...Read More

Company: Liebel-Flarsheim CoDate of Enforcement Report: 5/29/2002 Class: II PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2. REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID. CODE Serial Numbers: 0202-5000 to 0402-5126. RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim...Read More

Company: Fujifilm Medical Systems U.S.ADate of Enforcement Report: 5/29/02 Class: II PRODUCT Synapse Image and Information Management System. Recall # Z-1045-2. REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped. CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1. RECALLING FIRM/MANUFACTURER...Read More

Company: Sigma International MedinaDate of Enforcement Report: 5/8/02 Class: II PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R,...Read More

Company: Sunquest Information systems, aka Misys HealthcareDate of Enforcement Report: 5/1/02 Class: II PRODUCT Misys Laboratory Microbiology Module, Recall # Z-0916-2. REASON Software does not allow comments to be shown in some reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing. VOLUME...Read More

Company: Hitachi LtdDate of Enforcement Report: 5/1/02 Class: II PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2. REASON Possibility of false negative and false positive results being reported. CODE All units with software version 01-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...Read More