Siemens SOMATOM Definition — Class II medical device recall Z-0907-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-02-12, distributed nationwide. During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, De
| Recall number | Z-0907-2014 |
|---|---|
| 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 | 2013-11-15 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2015-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 147 |
| Reason classes | device malfunction, software |
| Serial numbers | 60121, 60124, 60173, 60331, 60398, 60404, 64019, 64067, 64071, 64081, 64082, 64103, 64114, 64172, 64179, 64181, 64194, 64232, 64243, 64260, 64270, 64297, 64299, 64304, 64308 and 122 more |
| Model numbers | 10430603, 10590000, 7740769, 8098027 |
Product
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Reason for recall
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
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-0907-2014. 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.