Device 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 )
Z-1993-2012
Product summary
- Event
- Event 62527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 254 units have been shipped to/installed in the U.S.
- Official record key
device-enforcement:Z-1993-2012
Official wording
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.
Code information: Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw
Distribution pattern: Worldwide Distribution (USA) nationwide
Derived failure modes
-
Device software or design
software issue