Ysio X — Class II medical device recall Z-1346-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-04-14, distributed nationwide. A patient image was assigned to a different patient during image recovery process. In the unlikely event of in
| Recall number | Z-1346-2021 |
|---|---|
| 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 | 2021-03-10 |
| Classified | 2021-04-02 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Serial numbers | 10039, 10041, 10042, 10043, 10045, 10046, 10048, 10049, 10053, 10054, 10055, 10057 |
| Model numbers | 11107464 |
Product
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
Reason for recall
A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted
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-1346-2021. 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.