Company: Veterans Health Administration Office of InformationDate of Enforcement Report: 11/19/03 Class: II PRODUCT VistA Blood Bank Software. Recall # B-0301-4. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version number 5.2, software patch LR*5.2*301. RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines,...Read More

Company: General Electric Medical Systems Information Technology,Date of Enforcement Report: 11/19/03 Class: II PRODUCT Solar 8000M Patient Monitor. Recall # Z-0092-04. REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display,...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/19/03 Class: II PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04. REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. CODE Version 1.02ER000 and...Read More