WhichRecall
Class IIReported 2026-02-04

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

Recalled by Canon Medical System, USA, INC.

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

Advertisement

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

Recall Number
Z-1178-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-19
Reported
2026-02-04
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Code Info
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement