Reported Feb 4, 2026 · Ongoing
Alphenix INFX-8000V, 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-8000V, interventional fluoroscopic x-ray system
- Lot codes and dates
- serial numbers
332 of 332 codes
B2A1522117E0514103B2A15X2238B2A1792589A2A2242418A2A21X2345B2A1692413A2A2152263A2A2262450A2A22Z2576W4A1252250A2A20Z2167W4A10X2001A2A2412831W1C0552181W1D0842501W4D13Z2452W4A1322350W4D1422467B2A1472002A1C1982123W2A1062134W1B08X2042W2A1072139W4A1242220A2A2382741B2A17Z2627A2A2152264W4C1362387W4D1422465D4W1262257W1D0892543W4D1462478W4A1182118W4A11X2133W4A11Z2167N/A DeinstalledA1B18Z7003W4A1252243DFP800A-0001A3552017W2A1092165W1D0882537A2A2122203W4A10Z2022W4B1332361A2A23Y2788W4A12Z2328B2A1662374W4A12Z2329B2A1622309B2A14X2056A2A2272459A2A2172291W4A1132061W1D0832488W1D0882536W2A0962022W2A0982038W2A0972026
- serial numbers
- Amount recalled
- 332 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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