Canon Medical recalls Alphenix INFX-8000C interventional fluoroscopy systems with loose ceiling screws that could cause movement issues or sensor errors. Affected units have specific serial numbers.
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
Canon Medical is recalling certain Alphenix INFX-8000C interventional fluoroscopy systems due to a risk that ceiling movement screws may become loose. This could lead to the system not moving properly, making unusual noises, or displaying sensor errors.
The fixing screws in the ceiling movement gear could become loose, causing the system to stop moving laterally, generate abnormal noises, or show sensor errors. This does not pose an immediate safety hazard like a fire or injury risk.
Healthcare facilities using the Alphenix INFX-8000C interventional fluoroscopy systems with specific serial numbers listed in the recall are most at risk. Patients and staff using these systems may experience temporary disruptions.
Check if your Alphenix INFX-8000C system has a serial number from the list provided in the recall notice. The serial numbers are detailed in the official recall record.
Verify if your system's serial number matches the list of affected units provided in the recall notice.
The recall is due to a potential issue with the fixing screws in the ceiling movement gear that could become loose, leading to movement problems or sensor errors.
Check if your Alphenix INFX-8000C system has a serial number from the list of affected units provided in the recall notice.
No, the recall does not require immediate discontinuation of use. The hazard is low risk and does not involve immediate safety threats.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1176-2026 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1176-2026 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
