Canon INFX-8000V Fluoroscopy Dose Rate Risk Recall

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Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Canon is recalling its INFX-8000V medical imaging systems due to a potential risk of exceeding safe radiation dose rates during biplane fluoroscopy procedures. This could lead to unnecessary radiation exposure for patients or staff if the system is used without proper monitoring.

Why it’s dangerous

The fluoroscopic dose rate might exceed the safe radiation levels during biplane imaging when the system is used without proper monitoring. This could result in unnecessary radiation exposure for patients and medical personnel during procedures like radiographic studies and interventions.

Who’s affected

Healthcare facilities using Canon's INFX-8000V systems with Alphenix i software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD are most at risk. Patients and medical staff during fluoroscopy procedures may be exposed to higher radiation levels than intended.

How to tell if you have this one

Check if your system includes the Alphenix i software with versions 8.0, 9.0, or 9.2 and the TFP 1200C FPD. The INFX-8000V is used for radiographic and fluoroscopic medical imaging procedures.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Details
Identify if your system has Alphenix i software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall notice does not specify any remedy or corrective action.

What should I do if I have this system?

The recall notice does not provide specific instructions for affected users.

How can I confirm if my system is affected?

Check if your system includes Alphenix i software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD.

Take action

Contact Canon Medical

We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1666-2022 — Canon Medical Canon Medical

Hello,

I own a Canon Medical that is covered by recall Z-1666-2022 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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Where this comes from

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.

Official source: FDA Recall #Z-1666-2022 (January 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1666-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.

Lower-risk recall