Company: Siemens Medical SolutionsDate of Enforcement Report: 4/30/03 Class: III PRODUCT ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03. REASON ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. CODE All Diacam, Multispect...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 4/30/03 Class: III PRODUCT Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03. REASON Under certain operating conditions, smart wash feature disables with multiple samples. CODE No codes. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter on February 24,...Read More