Recall Z-0948-2013 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
| Date | Mar 14, 2013 (initiated Nov 27, 2012) |
| Status | Terminated |
| Reason | Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality. |
| Root cause | Software design |
| Action | 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 informati |
| Quantity | 896 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122471 | SOMATOM DEFINITION Siemens Medical Systems, Inc., Sep 11, 2012 |