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

Medical DevicesSource: FDA (device) · Date: 2026-02-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Canon Medical System, USA, INC.
Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Reason / 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
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Recall initiated
2025-12-19
Code info
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Product quantity
3 units
Voluntary mandated
Voluntary: Firm initiated
City
Tustin
State
CA
Country
United States
Event id
97970
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