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Canon Medical System, USA, INC. recalls Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Recalled February 4, 2026 · FDA recall Z-1179-2026 · Canon Medical System, USA
Hazard
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 · FDA Class II
Units
332 units
Sold at
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Description
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
Product
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →