Device product
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Z-1029-2013
Product summary
- Event
- Event 64393
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1029-2013
Official wording
Reason: Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
Code information: Model #: 882456; Serial #: 2004
Distribution pattern: Distributed to one customer in Ohio.
Derived failure modes
-
Device software or design
software version 4.0.60605.0 that if they were to re-occur, could cause