Ziehm Vision RFD — Class II medical device recall Z-0578-2025
Ongoing recall by Orthoscan, Inc., reported 2024-12-11, distributed in PR. Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed device
| Recall number | Z-0578-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Orthoscan, Inc., Scottsdale, AZ, United States |
| Recall initiated | 2024-08-08 |
| Classified | 2024-12-02 |
| Reported by FDA | 2024-12-11 |
| Distributed | PR |
| Quantity | 30 |
| Reason classes | device malfunction |
| Serial numbers | 20048, 20240, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536 and 5 more |
Product
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Reason for recall
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
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-0578-2025. 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.