Device product
System INFX-8000F
Z-1176-2021
Product summary
- Event
- Event 87419
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 272 in total
- Official record key
device-enforcement:Z-1176-2021
Official wording
Reason: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Code information: Model: CAS-880A, CAS-830B
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.