Orthoscan, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0575-2025)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Ziehm Vision system, x-ray, tomography, computed.
Class II
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.
UDI: EZIEZIEHMVISIONFD1 Serial Numbers: 9246, 90155, 90416.
U.S. (including Puerto Rico).
FDA Mandated
