Canon Medical recalls Alphenix INFX-8000H interventional fluoroscopy systems due to potential ceiling movement issues from loose screws. 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 Alphenix INFX-8000H interventional fluoroscopy systems because loose ceiling screws could cause movement problems, noise, and sensor errors. This affects medical facilities using these systems for imaging procedures.
Loose fixing screws in the ceiling movement gear could prevent proper lateral movement of the X-ray arm. This might cause abnormal noise and sensor errors during use, but does not indicate immediate danger to users.
Medical facilities that own or use the Alphenix INFX-8000H systems are most at risk. The recall applies to specific serial numbers listed in the notice.
Check if your Alphenix INFX-8000H system has serial numbers D2A1672385, A2A20Z2165, or B2A1692426. These units were sold in the U.S. by Canon Medical System, USA, INC.
Identify if your system has serial numbers D2A1672385, A2A20Z2165, or B2A1692426.
The recall is due to a potential issue with ceiling movement screws that could cause movement problems, noise, and sensor errors.
Check if your Alphenix INFX-8000H system has the listed serial numbers. If so, contact Canon Medical for further instructions.
The recall does not mention injury risks; the issue is limited to mechanical problems that do not cause immediate danger.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1178-2026 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1178-2026 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.
