Ysiosystem with VC10 software version — Class II medical device recall Z-0841-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-04-06, distributed nationwide. Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully auto
| Recall number | Z-0841-2022 |
|---|---|
| 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 | 2022-01-31 |
| Classified | 2022-03-30 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 70 systems |
| Reason classes | software |
| Serial numbers | 20105, 20113, 20115, 20118, 21004, 21005, 21108, 21114, 21174, 21194, 21209, 22029, 22054, 22058, 22071, 22076, 22092, 22104, 22119, 22126, 22128, 22135, 22136, 22146, 22163 and 45 more |
| Model numbers | 10281013 |
Product
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Reason for recall
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
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-0841-2022. 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.