Company: GE Healthcare Advantage Workstations
Date of Enforcement Report:12/19/2007
Class:ll
PRODUCT
GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2, Recall # Z-0265-2008
REASON
Aortic Length over-estimated: Incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should not be used.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter letters dated September 10, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,518 units
DISTRIBUTION
Nationwide and Internationally
