Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Published December 11, 2024 · Recall initiated: August 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Orthoscan, Inc.
- Distributor
- U.S. (including Puerto Rico).
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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