Device product
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Z-2626-2016
Product summary
- Event
- Event 74840
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 systems
- Official record key
device-enforcement:Z-2626-2016
Official wording
Reason: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Code information: Model # 8098027 Serial # 96020, 96047, 96011, and 96029
Distribution pattern: Distributed to: MI, NY, CA, KY, ND, NE
Derived failure modes
-
Device software or design
error between the firmware and the software