Z-0579-2025 Class II Ongoing
FDA device recall Z-0579-2025 was initiated by Orthoscan, Inc. on August 8, 2024 and is designated Class II. 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 resp… The recall status is ongoing. Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- August 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 50
Product Description
Ziehm Vision RFD 3D. Interventinoal 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.
Distribution Pattern
U.S. (including Puerto Rico).
Code Information
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.