Device product
ProxiDiagnost N90
Z-3023-2020
Product summary
- Event
- Event 86416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71
- Official record key
device-enforcement:Z-3023-2020
Official wording
Reason: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Code information: All ProxiDiagnost N90 systems are affected.
Distribution pattern: United States
Derived failure modes
-
Unknown
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.