Orthoscan, Inc. recalls Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Recalled Product
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
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
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