SOMATOM Definition Flash — Class II medical device recall Z-0605-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-11-23, distributed nationwide. A problem can occur with the small light marker windows, used for the positioning laser and are integrated in
| Recall number | Z-0605-2017 |
|---|---|
| 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 | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Serial numbers | 64019, 64064, 64067, 64068, 64071, 64074, 64077, 64078, 64079, 64081, 64082, 64085, 64087, 64091, 64103, 64104, 64105, 64111, 64112, 64113, 64114, 64117, 64118, 64122, 64123 and 475 more |
Product
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS 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
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
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-0605-2017. 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.