Device product
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Z-1613-2016
Product summary
- Event
- Event 73977
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,386
- Official record key
device-enforcement:Z-1613-2016
Official wording
Reason: The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Code information: Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4
Distribution pattern: Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
Derived failure modes
-
Unknown
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.