Medical Device Recall: Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC. · December 19, 2025
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.
States Affected
NATIONWIDE
Quantity Affected
172 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1176-2026
Status: ongoing
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