Siemens Cios Alpha VA30-mobile X-Ray system — Class II medical device recall Z-1958-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-05-20, distributed nationwide. Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any ti
| Recall number | Z-1958-2020 |
|---|---|
| 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 | 2020-04-20 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Serial numbers | 40032, 40047, 40048, 40057, 40070, 40075, 40102, 40104, 40107, 40108, 40111, 40120, 40124, 40126, 40134, 40135 |
Product
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The 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
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
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-1958-2020. 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.