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