Company:GE Healthcare, LLC
Date of Enforcement Report 3/6/2013
Class ll:
PRODUCT
GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
Recall Number Z-0703-2013 and Z-0704-2013
REASON
It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 9/26/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
312 installed in US
DISTRIBUTION
Nationwide
___________________________________
