CIOS ALPHA — Class II medical device recall Z-0118-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-11-04, distributed nationwide. patient procedure interruption due to a potential system failure
| Recall number | Z-0118-2016 |
|---|---|
| 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 | 2015-08-17 |
| Classified | 2015-10-23 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 44 |
| Serial numbers | 10019, 10021, 10035, 10037, 10057, 10058, 10063, 10073, 10076, 10078, 10082, 10089, 10098, 10115, 10116, 11005, 11009, 11013, 11015, 11016, 11018, 11032, 11035, 11038, 11044 and 19 more |
| Model numbers | 10308191 |
Product
CIOS ALPHA; image intensified fluoroscopic x-ray system
Reason for recall
patient procedure interruption due to a potential system failure
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-0118-2016. 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.