Company: GE Healthcare
Date of Enforcement Report 10/1/2008
Class:ll
PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis, Recall # Z-1822-2008
REASON
Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover). This lost anatomy cannot be recovered or visualized by retrospective reconstruction processing.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
Nationwide and Internationally
