Device product
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Z-2256-2012
Product summary
- Event
- Event 62946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 254 total in the US
- Official record key
device-enforcement:Z-2256-2012
Official wording
Reason: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Code information: Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
Distribution pattern: Worldwide Distribution -- USA (nationwide) Distribution
Derived failure modes
-
Device software or design
Software issue