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.
Enforcement
- Recall Number
- Z-1350-2016
- Event ID
- 73639
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 20, 2016
- Initiation Date
- March 22, 2016
- Classification Date
- April 8, 2016
- Termination Date
- August 7, 2017
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
Description
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.
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
Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766
Distributed to: Cincinnati, OH.
1 CT system