Reported Feb 4, 2026 · Ongoing
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Canon Medical System, USA, 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: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Lot codes and dates
- serial numbers
98 of 98 codes
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
- serial numbers
- Amount recalled
- 98 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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