Device product
Ingenuity TF PET/CT. Diagnostic imaging system
Z-0897-2013
Product summary
- Event
- Event 64403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Unit
- Official record key
device-enforcement:Z-0897-2013
Official wording
Reason: The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Code information: Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
Distribution pattern: Distributed only in Ohio.
Derived failure modes
-
Unknown
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.