Reported Dec 11, 2024 · Ongoing
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Orthoscan, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthoscan, Inc. · 14555 N 82nd St · Scottsdale, AZ · 85260-2525
Is this the product you have?
- Ziehm Vision R. Iterventional fluoroscopic x-ray system
- Lot codes and dates
- UDIEZIEZIEHMVISIONR1
- Serial Numbers
1029510490106561071610997
- Amount recalled
- 5
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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