SOMATOM Definition AS System — Class II medical device recall Z-0742-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-12-21, distributed nationwide. Software update that provides software and firmware bug-fixes to improve system performance
| Recall number | Z-0742-2017 |
|---|---|
| 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 | 2016-11-15 |
| Classified | 2016-12-12 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2018-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 104 systems |
| Reason classes | software |
| Serial numbers | 64065, 64140, 64709, 64860, 65017, 65127, 65304, 65437, 65453, 65455, 65480, 65491, 65501, 65516, 65609, 65614, 65615, 65618, 65639, 65672, 65680, 65712, 65734, 65760, 65856 and 79 more |
Product
SOMATOM Definition AS System, x-ray, tomography, computed 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
Software update that provides software and firmware bug-fixes to improve system performance
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-0742-2017. 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.