Company: GE Healthcare, LLC
Date of Enforcement Report 10/5/11
Class ll:
PRODUCT
ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. Recall # Z-3282-2011
REASON
GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, byletters dated August 18, 2011.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
697
DISTRIBUTION
Nationwide and Internationally
