SOMATOM Definition Flash system — Class II medical device recall Z-0374-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-11-16, distributed nationwide. Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or
| Recall number | Z-0374-2017 |
|---|---|
| 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 | 2016-10-19 |
| Classified | 2016-11-08 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 57 systems |
| Model numbers | 10430603, 8098027 |
Product
SOMATOM Definition Flash system, x-ray, tomography, computed
Reason for recall
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
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-0374-2017. 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.