Cios Alpha — Class II medical device recall Z-2848-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-09-02, distributed nationwide. Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revi
| Recall number | Z-2848-2020 |
|---|---|
| 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 | 2020-07-14 |
| Classified | 2020-08-22 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-07-23 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Model numbers | 10308191, 10308194, 11105200 |
Product
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 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
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
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-2848-2020. 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.