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: Ochsner Clinical FoundationDate: 03/05/2002 Product: Investigational device The manual does not adequately describe how the CIC support staff prepares and maintains records of all IRB activities, including meeting minutes, records and reports associated with investigations, and archiving. The manual does not describe how data and information are gathered, stored, and analyzed to prevent research...Read More

“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures. IEEE-NIH_CBMS_Safety_Model-13Read More

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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: 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: 2/13/2002 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

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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

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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: 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: 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: Sunquest Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,...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

Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. 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: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. 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: 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: Sysmex CorpDate: 01/22/2002 Product name: Clinical laboratory diagnostic devices, including hematology, reticulocyte, urinalysis and coagulation analyzers Failure to establish and maintain documented procedures to control and verify the design of the device in order to ensure that specified design requirements are met, as specified in 21 CFR 820(a)(1). For example, there were no procedures...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 1/16/02 Class: III PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. REASON The software did not save oblique data correctly...Read More

Company: Siemens Medical Systems, INCDate of Enforcement Report: 11/16/01 Class: III PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. REASON...Read More

FDA withdrew recognition of this standard in May 2007 after it was obsoleted and replaced by ISO 62304. On Jan 14, 2002 FDA issued an update to their list of recognized standards for use by the Office of Device Evaluation. A new software standard was recognized. This is the AAMI/ANSI SW 68 Medical Device Software...Read More

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Company: Pharmaceutical Distribution SystemsDate: 01/03/2002 Product: Drug products Failure to exercise appropriate controls over and to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment used in the manufacturing, processing, and packaging of a drug product according to a written program designed to assure proper performance (21 CFR 211.68) in that, the installation qualification...Read More

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Company: Natural Technology Inc.Date: 12/14/01 Product: Drug products Failure to maintain records of calibration checks and inspections of automatic, mechanical, or electronic equipment [21 CFR 211.68(a)]. For example, incubator and refrigerator thermometers associated with equipment that stores microbiological media have not been calibrated. FDA District: Dallas District OfficeRead More

Company: Medical Device Services Inc.Date: 12/13/2001 Product Name: Single use medical devices, such as general surgery, orthopedic, laparoscopic and cardiovascular instruments, including biopsy forceps, needles, burrs, drill bits, saw blades, trocars, retractors, blood pressure cuffs, catheters and guidewires Failure to validate computer software for its intended use according to an established protocol prior to approval...Read More

Company: Cardinal Enterprises Inc. Date: 12/07/2001 Product: Drug products Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/28/01 Class: II PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing...Read More

Company: Multidata Systems International Corp.Date of Enforcement Report: 11/28/01 Class: II PRODUCT Radiation Treatment Planning Decision Support System (DSS), Recall # Z-0213-2. REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. CODE All versions. RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO, by letter...Read More

Company: Radionics, A Division of Tyco HealthcareDate of Enforcement Report: 11/21/01 Class: II PRODUCT Radionics XKnife RT Software, Recall # Z-0275-2. REASON Software error may cause incorrect jaw settings for a record/verify system. CODE Version 1.02 and lower. RECALLING FIRM/ MANFACTURER Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm...Read More

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Company: Novametrix Medical Systems, IncDate of Enforcement Report: 11/7/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM...Read More

Company: Marconi Medical Systems, IncClass: II Date of Enforcement Report: 10/31/01 RECALL NUMBER, PRODUCT AND CODE: Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software. REASON: Software in version 2.0 / 2.01 software may lead to improper patient treatment. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems,...Read More

Company: Bunnell Inc.Date: 10/29/01 Product: High frequency jet ventilators and accessories for neonatal use Failure to validate processes that cannot by fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example the compliant handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated....Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” —...Read More

Company: Nihon Kohden, IncDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on...Read More

Company: Marconi Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0057-2, Marconi MX8000 Computed Tomography X-ray Codes: All Marconi MX8000 CT Scanners running with Version 2.0 sofware. REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems, Inc., Highland Heights,...Read More

Company: Dade Behring Marburg GMBHDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer. Codes: Software Version 2.2 Code OVIO03 REASON: Falsely shortened APTT value. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH, Marburg, Germany RECALLED BY: Dade Behring, Inc., Newark, DE, by letter on 6/25/01 FIRM INITIATED...Read More

Company: TegimentaDate of Enforcement Report: 10/17/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4. REASON: If the operator fails to...Read More

Company: Sorenson Development IncDate: 10/17/01 Product: Infusion pumps and other medical devices Failure to validate processes with a high degree of assurance where the results cannot be fully verified by subsequent inspection and testing, and have those processes approved and documented according to established procedures, as required by 21 CFR 820.75(a). Specifically, revalidation of the...Read More

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Company: Bayer CorporationDate of Enforcement Report: 10/10/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system. Codes: Software versions AE through AL, except version...Read More