Device product
SOMATOM Definition AS system, x-ray, tomography, computed
Z-0373-2017
Product summary
- Event
- Event 75509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 systems distributed in USA
- Official record key
device-enforcement:Z-0373-2017
Official wording
Reason: Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
Code information: Model Numbers: 8098027 10430603
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.