Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alphenix INFX-8000C Recalled by Canon Medical System, USA, INC. Due to It has been discovered that there is a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.
Affected Products
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Quantity: 172 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Canon Medical System, USA, INC.
Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report