medical Class II Updated 2024-12-11

Orthoscan, Inc. recalls Ziehm Solo. Digital Mobile C-arm

Recalled Product

Ziehm Solo. Digital Mobile C-arm

Hazard / Issue

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.

Issued by

FDA

Distribution: U.S. (including Puerto Rico).
Lot/Code Info: UDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.
View official government recall

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