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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Canon Medical System, USA
- Product type
- Interventional Fluoroscopic X-Ray System
- Model numbers
- serial numbers: W1C0632284, W4A1282279, W4A12Z2324, A2A2222381, A2A2392756, A3517001, A2A2352683, A2A2072087 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Alphenix INFX-8000C is an advanced interventional fluoroscopic x-ray system designed for medical imaging. Healthcare facilities utilize this system for various diagnostic and surgical procedures.
Why This Is Dangerous
The potential loosening of screws in the ceiling movement gear can prevent proper operation of the x-ray system, leading to operational failures and possible safety hazards during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers must cease using the affected x-ray systems, which can disrupt medical services and patient care.
Practical Guidance
How to identify if yours is affected
- Locate the serial number on your Alphenix INFX-8000C system.
- Compare the serial number to the list of recalled models provided by Canon Medical.
- Contact your healthcare provider to verify if your device is affected.
Where to find product info
Serial numbers can typically be found on the device's information label or manufacturer's plate.
What timeline to expect
Expect a response for refund processing or instructions within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Canon Medical.
- Reach out to your healthcare provider for further assistance.
- Contact the FDA if there is no response after multiple inquiries.
How to prevent similar issues
- Ensure to check for recent recalls before purchasing medical devices.
- Inquire about warranty and service agreements for medical equipment.
- Stay informed on manufacturer updates and safety notices.
Documentation advice
Keep a record of all communications regarding the recall, including emails, letters, and any instructions received.
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Product Details
The recall involves the Canon Alphenix INFX-8000C interventional fluoroscopic x-ray system. The affected serial numbers include W1C0632284, W4A1282279, and others. These units were distributed worldwide, including the U.S. and the Dominican Republic.
Key Facts
- Potential for ceiling movement failure
- Stop using immediately
- Contact Canon Medical for instructions
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