Device product
SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
Z-1350-2016
Product summary
- Event
- Event 73639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 CT system
- Official record key
device-enforcement:Z-1350-2016
Official wording
Reason: Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation
Code information: Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766
Distribution pattern: Distributed to: Cincinnati, OH.
Derived failure modes
-
Unknown
Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation