***Updated 12/4/23*** — Class II medical device recall Z-0196-2024
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-11-08, distributed nationwide. Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN
| Recall number | Z-0196-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2023-09-12 |
| Classified | 2023-10-27 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869153506, 04056869246628 |
| Serial numbers | 50030, 50032, 50033, 50048, 50050, 50051, 50072, 50073, 50075, 50079, 50081, 50088, 50094, 50096, 50098, 50101, 50107, 50109, 50111, 50120, 50122, 50123, 50124, 50127, 50129 and 156 more |
Product
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
Reason for recall
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
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-0196-2024. 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.