Siemens Somatom CTs equipped with software syngo CT2010A — Class II medical device recall Z-0948-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-03-20, distributed nationwide. Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
| Recall number | Z-0948-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2012-11-27 |
| Classified | 2013-03-14 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 896 |
| Reason classes | device malfunction |
| Model numbers | 10430603, 10590000, 7740769, 8098027 |
Product
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Reason for recall
Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0948-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.