Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ziehm Vision FD. Interventional fluoroscopic x-ray system Recalled by Orthoscan, Inc. Due to Ziehm Imaging, Inc., distributor, have been informed by...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthoscan, Inc. directly.
Affected Products
Ziehm Vision FD. Interventional fluoroscopic x-ray system
Quantity: 22
Why Was This Recalled?
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.
Where Was This Sold?
U.S. (including Puerto Rico).
About Orthoscan, Inc.
Orthoscan, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report