Company: Shimadzu Medical SystemsDate of Enforcement Report: 9/7/05 Class:II PRODUCT C-Vision Angiographic X-Ray System, Model IVS-100, Recall # Z-1420-05 REASON Fluro exposure stuck open, will not terminate. CODE Software versions before 3.0 RECALLING FIRM/MANUFACTURER Recalling Firm: Shimadzu Medical Systems, Torrance, CA, by letter in April 2002. Manufacturer: Shimadzu Corporation, Kyoto, Japan. Firm initiated recall is...Read More

Company: Philips Medical Systems (Cleveland) Inc.Date of Enforcement Report: 9/7/05 Class:II PRODUCT a) Brilliance CT System, 40 channel configuration using version 1.2 software, Recall # Z-1409-05; b) Brilliance CT System, 16 Power configuration using version 1.2 or 1.2.1 software, Recall # Z-1410-05; c) Brilliance 16, 10, and 6 configuration (water cooled version) using 1.0. 1.1,...Read More

Company: Biosound Esaote, IncDate of Enforcement Report: 9/7/05 Class:II PRODUCT a) MyLab30CV Ultrasound Imaging System; model 9807300000, Recall # Z-1401-05; b) MyLab30CV Ultrasound Imaging System; model 9807300001, Recall # Z-1402-05; c) MyLab25 Ultrasound Imaging System; model 9807300002, Recall # Z-1403-05 REASON Data maybe corrupted upon re-opening archived files. CODE a) All units using software version...Read More

Company: Beckman Coulter, IncDate of Enforcement Report:9/7/05 Class:II PRODUCT Aqueduct Hematology Workflow Manager, software, Part Number AQDCT, Recall # Z-1440-05 REASON Potential for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow...Read More