Ysio — Class II medical device recall Z-1501-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-03-25, distributed nationwide. The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this s
| Recall number | Z-1501-2020 |
|---|---|
| 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 | 2020-02-10 |
| Classified | 2020-03-16 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Serial numbers | 20034, 20035, 20045, 20047, 20088, 20089, 20093, 20094, 20106, 20107, 20110, 20113, 20149, 20155, 20159, 20167, 20185, 20193, 21001, 21006, 21013, 21023, 21031, 21037, 21039 and 56 more |
| Model numbers | 10281013 |
Product
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Reason for recall
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.
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-1501-2020. 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.