Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography
FDA device recall Z-0948-2013 · posted 2013-03-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
- Action taken
- Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated November 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The correction for this problem will be available with Service Pack 1 for syngo CT2011A And Service Pack 4 for syngo CT2012B. Both Service pack are planned to be released starting February 2013. Systems still running on syngo CT2010A or syngo CT2010B are already scheduled to be upgraded to syngo CT2011A or syngo CT2012B respectively. Contact your local Siemens Application Specialist for additional information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 896
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-11-27
- Date posted
- 2013-03-14
- Date terminated
- 2014-01-31
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM DEFINITION (K122471) | Siemens Medical Systems, Inc. | 2012-09-11 |