Device product
Celesteion PCA-9000A/2 PET/CT System
Z-0005-2016
Product summary
- Event
- Event 71763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0005-2016
Official wording
Reason: It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Code information: Model: TSX-301 CI6A with system software V7.0 SPOO04J
Distribution pattern: US Distribution to the state of Nevada.
Derived failure modes
-
Device software or design
software problem