Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Recall #Z-1178-2026 — Class II — December 19, 2025
Product Description
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
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
Recalling Firm
Canon Medical System, USA, INC. — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Code Information
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated