Cios Alpha — Class II medical device recall Z-1958-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-07-08, distributed nationwide. under certain circumstances the Cios Alpha system may freeze during a procedure.
| Recall number | Z-1958-2015 |
|---|---|
| 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 | 2015-05-05 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 37 |
| Serial numbers | 10019, 10021, 10035, 10037, 10057, 10058, 10063, 10073, 10076, 10078, 10082, 10089, 10096, 10098, 10115, 10116, 11005, 11009, 11013, 11015, 11016, 11018, 11032, 11035, 11038 and 12 more |
Product
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Reason for recall
under certain circumstances the Cios Alpha system may freeze during a procedure.
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-1958-2015. 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.