HIGH

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
December 19, 2025
Hazard Level
HIGH
Brand
Canon Medical System, USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall affects 98 units of the Alphenix INFX-8000F interventional fluoroscopic x-ray system. The devices were distributed worldwide, including the US and the Dominican Republic.

The Hazard

Loose fixing screws in the ceiling movement gear may prevent lateral movement of the system. This can generate abnormal noise and trigger sensor errors, posing a significant risk in a medical setting.

Reported Incidents

As of the report date, no injuries or incidents have been specifically documented related to this recall. The potential for malfunction could lead to serious safety concerns.

What to Do

Healthcare providers should stop using the Alphenix INFX-8000F immediately. Follow the recall instructions provided by Canon Medical System, USA, or consult your healthcare provider.

Contact Information

For further information, contact Canon Medical System, USA at their official website or customer service hotline.

Key Facts

  • 98 units recalled
  • Loose screws may cause malfunction
  • Stop using immediately
  • Distributed worldwide
  • Contact manufacturer for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeInterventional Fluoroscopic X-ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
serial numbers: W1C0582204
B2A1582208
W2A1052118
A3582035
A2A2362689
+15 more
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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