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: D2A1672385, A2A20Z2165, B2A1692426.
- 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-8000H is an interventional fluoroscopic x-ray system used in medical settings for imaging during procedures. Healthcare providers rely on it for accurate diagnostics and treatment planning.
Why This Is Dangerous
The potential loosening of screws in the ceiling movement gear could impair the device's functionality, leading to operational failures during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers must halt the use of the affected x-ray systems immediately, which could disrupt patient care and operational workflows.
Practical Guidance
How to identify if yours is affected
- Locate the serial number on the device and check against the recalled models.
- Ensure the system is not in use before checking for the serial number.
- Contact Canon Medical System for guidance if unsure about the device status.
Where to find product info
The serial number can typically be found on the device's back or side panel.
What timeline to expect
Expect a response for refunds or replacements within 4-6 weeks after contacting Canon Medical System.
If the manufacturer is unresponsive
- Follow up with Canon Medical via phone or email.
- Document all correspondence and escalate the issue if necessary.
How to prevent similar issues
- When purchasing medical devices, check for safety certifications and recalls.
Documentation advice
Keep records of your device's serial number, purchase receipt, and any communication with the manufacturer.
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Product Details
The recalled models include serial numbers: D2A1672385, A2A20Z2165, and B2A1692426. These devices have been distributed worldwide, including the United States and the Dominican Republic.
Key Facts
- Models: D2A1672385, A2A20Z2165, B2A1692426
- Worldwide distribution; US and Dominican Republic
- Class II recall due to high hazard level
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