Cios Alpha — Class II medical device recall Z-1278-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-04-06, distributed nationwide. Software issues on Cios Alpha mobile C-Arm system
| Recall number | Z-1278-2016 |
|---|---|
| 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 | 2016-02-19 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 89 systems |
| Reason classes | software |
| Model numbers | 10308191 |
Product
Cios Alpha, mobile X-ray system
Reason for recall
Software issues on Cios Alpha mobile C-Arm system
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-1278-2016. 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.