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: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113 +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-8000F is an advanced interventional fluoroscopic x-ray system used in medical settings for imaging and guiding procedures. Healthcare providers rely on its functionality for accurate diagnostics and patient care.
Why This Is Dangerous
The risk arises from loose screws in the ceiling movement gear of the x-ray system. This defect can hinder movement and generate noise, affecting the system's performance and potentially compromising patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate cessation of use by healthcare providers, potentially affecting patient care and leading to operational disruptions in facilities.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check against the recall list to confirm if your unit is affected.
- Review any documentation that came with the device for additional information.
Where to find product info
The model numbers can typically be found on the device's identification plate or in the user manual provided by the manufacturer.
What timeline to expect
Expect a timeline of 4-8 weeks for refund processing once your request is submitted.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Reach out to the FDA or CPSC for assistance.
- Consider legal options if necessary.
How to prevent similar issues
- When purchasing medical devices, ensure they meet safety certifications.
- Regularly check for recalls on devices in use.
- Consult peer reviews and safety ratings before selecting equipment.
Documentation advice
Keep records of your purchase, correspondence with the manufacturer, and any documentation from the recall process.
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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.
Key Facts
- Loose screws may cause malfunction
- Stop using immediately
- Contact manufacturer for instructions
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Safety Guide
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