Recall
FDAHealthDecember 19, 2025

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

⚠️ 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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 19, 2025

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

What's affected?

Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Lot code
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.

Additional details

serial numbers: D2A1672385, A2A20Z2165, B2A1692426.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.

View original FDA notice →

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