SOMATOM Definition Flash — Class II medical device recall Z-0608-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-11-23, distributed nationwide. Siemens is releasing a software update that provides bug-fixes to improve system performance for customers wit
| Recall number | Z-0608-2017 |
|---|---|
| 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 | 2016-11-02 |
| Classified | 2016-11-17 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 7 systems |
| Reason classes | software |
| Serial numbers | 74192, 83387, 83398, 96011, 96020, 96029, 96047 |
| Model numbers | 10430603 |
Product
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles
Reason for recall
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
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-0608-2017. 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.