FDA Device recall Z-0578-2025
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Ziehm Vision RFD. Interventional fluoroscopic x-ray system by Orthoscan, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0578-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthoscan |
| Distribution | PR |
Product
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Reason
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.
Identifiers
| code_info | UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375…UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0578-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.