Company: Siemens Medical Systems, Inc.Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 – Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and...Read More
Company: Medica Corp.Date of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. CODES: EasyBlood Gas Analyzers with Software version below M4.20. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00....Read More
Company: DADE BEHRING, INCDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 REASON: Incorrect low results for a number of patient samples. CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More
Company: Baxter Healthcare CorporationDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake,...Read More
