Cios Alpha — Class II medical device recall Z-0782-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-01-15, distributed nationwide. During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm ho
| Recall number | Z-0782-2020 |
|---|---|
| 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 | 2019-11-25 |
| Classified | 2020-01-07 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-05-06 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure, packaging, device malfunction |
| Serial numbers | 10019, 10021, 10035, 10037, 10057, 10058, 10063, 10076, 10082, 10096, 10115, 10116, 11005, 11009, 11013, 11015, 11016, 11018, 11032, 11035, 11038, 11044, 11056, 11064, 11066 and 165 more |
| Model numbers | 10308191 |
Product
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Reason for recall
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
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-0782-2020. 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.