Canon Medical System, USA, INC. recalls Alphenix INFX-8000F, interventional fluoroscopic x-ray system

Recall date

December 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1177-2026

FDA classification

Class II

Brand / firm

Canon Medical System, USA, INC.

Sold / distributed

Worldwide distribution - US Nationwide and the country of Dominican Republic.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alphenix INFX-8000F, interventional fluoroscopic x-ray system