—#144645

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143400
Affected lot / code info: Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed to: Cincinnati, OH.

Timeline

Recall initiated: 2016-03-22
Posted by FDA: 2016-04-08
Terminated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144645. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.