Reported Feb 4, 2026 · Ongoing
Alphenix INFX-8000C, 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-8000C, interventional fluoroscopic x-ray system
- Lot codes and dates
- serial numbers
172 of 172 codes
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
- serial numbers
- Amount recalled
- 172 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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