Recall Z-1993-2012— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-04-04, terminated 2013-01-10. FDA's recall record names no specific 510(k) clearance for this event. 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 ). Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-04
- Terminated
- 2013-01-10
- Firm location
- Waukesha, WI, United States
Product description
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 )
Reason for recall
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Data sourced from openFDA. This site is unofficial and independent of the FDA.