Tag

recall

Software Recall

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, 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Philips Medical SystemsDate of Enforcement Report: 5/1/2002 Class: III PRODUCT Integris H5000, Angiographic X-ray system. Recall # Z-0924-2. REASON System may occasionally re-boot during a patient examination. CODE Units with SYSCO software version 11.1.2. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001., Manufacturer: Philips...
Read More
Company: Roche Diagnostics CorpDate of Enforcement Report: 5/1/02 Class: II PRODUCT All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2. a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200; b) DataCare ABG Data Management System for use in a blood gas point of care testing...
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
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: Sunquest Information Systems, IncDate of Enforcement Report: 4/24/02 Class: II PRODUCT Misys Laboratory for Windows version 5.3. Recall # Z-0888-2. CODE REASON Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results. Versions 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,...
Read More
Company: Zoll Medical CorpDate of Enforcement Report: 4/24/02 Class: I PRODUCT a) Zoll M Series Advisory Defibrillator. Recall # Z-0893-2; b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2. REASON Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock. CODE a) Serial Numbers: T98F00046-T01K27762 with System Software Version below...
Read More
Company: Misys Healthcare SystemsDate of Enforcement Report: 4/17/02 Class: II PRODUCT Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2. REASON Software anomaly may allow patient results to be transposed against another patient header or identification. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002....
Read More
Class: III Aeroset Chloestorol Reagent Lot 82099HW00. Firm’s list no. 7D62-01. Manufacturer: Abbott Laboratories, Inc., Sout Pasadena, CA Recalled by: Manufacturer, by letters on April 17, 2002. Firm initiated recall is ongoing Distribution: Nationwide and internatinally; 715 units were distributed Reason: Stability may be compromised over time, product currently OK Recall number: Z-1031-2
Read More
Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/10/02 Class: II PRODUCT FlexiLab Laboratory Information System. Recall # Z-0710-2. REASON Date Format Issue–Flexilab Software converts specimen collect and receipt dates to American standard format ‘mm/dd/yyyy’. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect...
Read More
Company: Roche Diagnostics CorpDate of Enforcement Report: 4/10/02 Class: II PRODUCT All DataCare Systems Software, as follows: a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200 b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201...
Read More
Company: Siemens AG Medical EngineeringDate of Enforcement Report: 3/27/02 Class: III PRODUCT a) ACOM.PC Angiographic X-ray System; b) Digital Image Communications System. Recall # Z-0603-2. REASON Software problem in recording heights and weights. CODE Siemens part number: a) ACOM.PC V3.0-4371105 b) Quantcor V4.0-4786898, 5915553, 5915579. Equipment Concerned: Product: Part No. Serial No. LVA V 4.0...
Read More
Company: Bayer CorporationDate of Enforcement Report: 3/27/02 Class: III PRODUCT Clinitek 100 Software Kit. Recall # Z-0634-2. REASON False negative results when high concentrations of ketone exist. CODE Version 7.00. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Elkhart, IN, by telephone and fax on January 21, 2002. Manufacturer: Bayer Corporation, Mishawaka, IN. Firm initiated recall is...
Read More
Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/24/02 Class: II PRODUCT AEROSET System Software v1.00ER005.2 and v1.0ER005 Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2. REASON System may incorrectly associate sample ID & test requests undercertain conditions of non-bar coded or unreadable bar coded samples. CODE All Codes are affected by this field correction....
Read More
Company: Sunquest Information Systems IncDate of Enforcement Report: 3/6/02 Class: II PRODUCT FlexiLab Laboratory Information System, Version 5.2, 5.23, and 5.3, Recall # Z-0531-02. REASON Software glitch can cause results to be filed under an incorrect accession number under certain conditions. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems Inc., Tucson, AZ,...
Read More
Company: ADAC LaboratoriesDate of Enforcement Report: 2/13/02 Class: II PRODUCT ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02. REASON A Software problem that could result in incorrect radiation dosage being applied. CODE Model: 9200-0579A. RECALLING FIRM/MANUFACTURER ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm...
Read More
Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Laboratory Information System, Recall # B-0710-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.23 and 5.3 with RBR module. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 19, 2001....
Read More
Company: Sunquest Information Systems, Inc Date of Enforcement Report: 2/13/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0711-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2 and 5.23. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated June 22,...
Read More
Company: Sunquest Information Systems, IncDate of Enforcement Report: 2/13/2002 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0709-2. REASON Blood bank computer system, which had a software glitch or defect, was distributed. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 13,...
Read More
Company: Roche Diagnostics CorpDate of Enforcement Report: 2/6/02 Class: II PRODUCT All DataCare Systems Software, as follows: A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S. B) DataCare Networked Client Computer for DataCare ABG Data Management System...
Read More
Company: Mediware Information Systems, IncDate of Enforcement Report: 2/30/02 Class: III PRODUCT Hemocare Blood Bank Data Management System Software, Recall # B-0626-2. REASON Computer software that could allow the assignment of an extended expiration date to blood products was distributed. CODE Versions 5.1, 5.2, 5.2a, and 5.2b. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY...
Read More
Company: Dade Behring, IncDate of Enforcement Report: 1/30/02 Class: II PRODUCT Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02. REASON Instructions to software revision are missing a step. CODE Revision 5.2 The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218,...
Read More
Company: Biochem Immunosystems (U.S.), IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02. REASON Samples were not picked up and added to the dilution tube. CODE Version 2.2a Catalog # PL01. RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA,...
Read More
Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0670-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0668-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: 111 PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0671-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0669-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
1 50 51 52 53 54 56

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.