Cios Alpha — Class II medical device recall Z-2887-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-09-02, distributed in AZ, CA, FL, IL, MD, MN, NC, NE…. Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous
| Recall number | Z-2887-2020 |
|---|---|
| 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 | 2020-07-30 |
| Classified | 2020-08-26 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-05-20 |
| Distributed | AZ, CA, FL, IL, MD, MN, NC, NE, NY, OH, OK, SC, TX, VA, WI |
| Quantity | 329 units |
Product
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Reason for recall
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
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-2887-2020. 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.