Recall Z-1350-2016 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
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.
| Date | Apr 8, 2016 (initiated Mar 22, 2016) |
| Status | Terminated |
| 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 |
| Root cause | Other |
| Action | Siemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed. |
| Quantity | 1 CT system |
| Distribution | Distributed to: Cincinnati, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143400 | SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc., Apr 8, 2015 |