SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconst
FDA device recall Z-1350-2016 · posted 2016-04-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1 CT system
- Distribution
- Distributed to: Cincinnati, OH.
- Date initiated
- 2016-03-22
- Date posted
- 2016-04-08
- Date terminated
- 2017-08-07
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM Definition AS/AS+ (K143400) | Siemens Medical Solutions USA, Inc. | 2015-04-08 |