SOMATOM Emotion 6 — Class II medical device recall Z-1934-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-07-08, distributed nationwide. A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance W
| Recall number | Z-1934-2015 |
|---|---|
| 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 | 2015-06-04 |
| Classified | 2015-06-27 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 40 total |
| Serial numbers | 29161, 29165, 29176, 29181, 29185, 29186, 29198 |
| Model numbers | 10165888 |
Product
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Reason for recall
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
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-1934-2015. 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.