Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Canon Medical System, USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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: B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263 +12 more
- Sold at
- Unknown
- 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-8000V is an interventional fluoroscopic x-ray system used in medical procedures to visualize internal structures. It is commonly used in hospitals for diagnostics and interventions.
Why This Is Dangerous
The potential for loose fixing screws can lead to a loss of control over the device's ceiling movement, which is crucial for accurate imaging during procedures. This defect poses risks of operational failure and sensor errors.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses an immediate safety concern for healthcare providers. It requires urgent action to prevent potential operational failures during medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the serial number on your device.
- Compare your serial number to those listed in the recall notice.
- Check for any abnormal sounds or sensor errors during operation.
Where to find product info
Serial numbers can typically be found on the device's back panel or within the user manual.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-8 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to your healthcare provider for additional support.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Always check for recalls before purchasing medical equipment.
- Maintain regular inspections of medical devices for wear and tear.
Documentation advice
Keep records of your device's serial number, any correspondence with the manufacturer, and notes of any issues experienced.
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Product Details
The recall affects the Alphenix INFX-8000V interventional fluoroscopic x-ray system. The affected models include serial numbers such as B2A1522117, E0514103, and A2A2152263. The devices were distributed worldwide, including US and Dominican Republic.
Key Facts
- Loose screws may prevent device movement
- Contact Canon Medical System for instructions
- Distribute notifications via letter
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Safety Guide
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