interventional fluoroscopic x-ray system — Class II medical device recall Z-2021-2025
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-07-09. In very rare situations, communication between the sensor measuring dose applied to the area and the correspon
| Recall number | Z-2021-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-05-15 |
| Classified | 2025-06-27 |
| Reported by FDA | 2025-07-09 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869295923 |
Product
interventional fluoroscopic x-ray system
Reason for recall
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
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-2021-2025. 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.