September 3, 2006
Company: Varian Medical Systems Date of Enforcement Report:8/23/2006 Class:ll PRODUCT a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row, part number GM11005400, for the GammaMed model 12i radionuclide applicator system, Recall # Z-1398-06; b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed...
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Company: AGFA Corp., Date of Enforcement Report:8/23/2006 Class:lI PRODUCT Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06. REASON A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators. CODE...
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Recipient: Vapotherm IncProduct:”Vapotherm 20001″ respiratory gas humidifier Date: 6/12/06 Failure to verify and validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, CAPA 05-032 includes a request to review cleaning protocols for improvement in existing cleaning...
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Recipient: Sonotech Inc.Product:Ultrabio Sterile ultrasound coupling gel Date:8/8/06 Failure to validate processes that cannot be fully verified by subsequent inspection and test; failure to establish and maintain procedures for finished device acceptance; failure to maintain a device master record that referred to the location of the packaging and labeling specifications; failure to conduct quality audits...
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Company: Radiometer America, Inc, Date of Enforcement Report:8/16/2006 Class:lIl PRODUCT ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06 REASON ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched.. CODE Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx RECALLING FIRM/MANUFACTURER Recalling Firm: Radiometer America, Inc., Westlake,...
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Company:Radiometer America Inc. Date of Enforcement Report:8/16/2006 Class:lI PRODUCT a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series, Recall # Z-1317-06; b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series, Recall # Z-1318-06 REASON Software defect. pO2 and pCO2 sample test results run on the firm’s ABL700/800 Series Blood Gas Analyzers...
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Recipient: Pointe Scientific Inc.Product:Hemoglobin A1c, Liquid Glucose Hexokinase, Liquid Alkaline Phosphatase, Liquid Auto Density Lipoprotein (Auto HDL) Cholesterol and other chemical analyzersr Date: 8/11/06 Failure to maintain procedures to ensure that the specified design requirements are met; failure to review all complaints to determine whether an investigation is necessary; failure to maintain procedures for implementing...
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Company: Immucor, Inc., Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Galileo Automated Blood Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies and compatibility testing), Recall #B-1645-6 REASON Blood Bank Analyzer, with a software glitch, was distributed. CODE atalog...
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Company: Edwards Lifesciences Llc, Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06 REASON Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the...
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FDA’s Center for Biologics Evaluation and Research issued the following: “Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002” This guide mentions software and computer systems in one paragraph which is provided below: “Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for...
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Recipient:Aksys Ltd..Product:Aksys PHD Personal Hemodialysis System Date: 6/806 Our records do not show that you obtained marketing clearance or approval before you began offering your device for sale with a modified treatment length. The device was cleared via a premarket notification (510(k)) _____, on _____, with a specified treatment length of _____ using a _____....
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Company:ABX Diagnostics Date of Enforcement Report:8/23/2006 Class:lll PRODUCT ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06 REASON Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.. CODE All serial numbers, all software versions. RECALLING FIRM/MANUFACTURER Recalling Firm: ABX Diagnostics, Inc., Irvine,...
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