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.
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