Company:GE Healthcare
Date of Enforcement Report 7/25/12
Class ll:
PRODUCT
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Recall Number Z-1993-2012
REASON
GE Healthcare hos become aware of o software issue on the interfoce of the mobile radiogrophic product, Optima XR200amx, ond Optima XR22Oamx reloted to Visual indicotion as mandoted by the US Code of Federol Regulations (21CFR) and IEC 60601-1-3.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 4/4/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide and Internationally
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