Device product
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Z-0199-2013
Product summary
- Event
- Event 63597
- Status
- Terminated
- Classification
- Class II
- Quantity
- 364 total units installed in US
- Official record key
device-enforcement:Z-0199-2013
Official wording
Reason: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Code information: part numbers: 5555000-3, 5555000-4
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
firmware issue