Ysio Max — Class II medical device recall Z-1339-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-02-26, distributed nationwide. A software bug may lead to one image to be assigned to two different patients, which could potentially affect
| Recall number | Z-1339-2020 |
|---|---|
| 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 | 2020-01-08 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 507 |
| Reason classes | software |
| Serial numbers | 24014, 24015, 24024, 24025, 24026, 24028, 24033, 24034, 24037, 24038, 24039, 24046, 24048, 24049, 24051, 24052, 24053, 24058, 24059, 24063, 24075, 24077, 24081, 24082, 24083 and 475 more |
| Model numbers | 10762470 |
Product
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography.
Reason for recall
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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-1339-2020. 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.