Device product
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Z-1666-2022
Product summary
- Event
- Event 90737
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 systems
- Official record key
device-enforcement:Z-1666-2022
Official wording
Reason: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Code information: Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.