Recall archive / FDA device enforcement
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system — FDA record Z-0579-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ziehm Vision RFD 3D. Interventinoal 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.
- Classification
- Class II
- Recalling firm
- Orthoscan, Inc.
- Quantity
- 50
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0579-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: EZIEZIEHMVISIONRFD3D1. Serial Numbers: 21118, 21212, 22040, 22710, 22764, 23247, 23248, 23255, 23257, 23258, 23259, 23260, 23327, 23328, 23329, 23456, 23457, 23458, 23459, 23653, 23654, 23655, 23656, 23657, 23666, 23667, 23668, 23669, 23670, 23671, 23672, 23673, 23674, 23723, 23740, 23744, 23745, 23746, 23747, 23748, 23749, 23750, 23751, 23752, 23753, 23775, 23801, 23802, 23828, 23849. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. (including Puerto Rico).
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 11, 2024
- Recall initiation date
- Aug 8, 2024
- Center classification date
- Dec 2, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.