Cios Alpha — Class II medical device recall Z-1298-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-05-15, distributed nationwide. Continuous operation at very high tube output may result in increased wear of the radiation emitting component
| Recall number | Z-1298-2019 |
|---|---|
| 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 | 2019-03-18 |
| Classified | 2019-05-08 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 257 |
| Serial numbers | 10019, 10021, 10035, 10037, 10057, 10058, 10063, 10076, 10078, 10082, 10089, 10096, 10115, 10116, 11005, 11009, 11013, 11015, 11016, 11018, 11032, 11035, 11038, 11044, 11056 and 232 more |
| Model numbers | 10308191 |
Product
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: 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
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
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-1298-2019. 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.