Canon INFX-8000C X-ray System Recall: Image Shift Risk

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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 Medical is recalling its INFX-8000C X-ray systems (models CAS-880A and CAS-830B) because the x-ray field might shift relative to the display screen at some angles. This could lead to inaccurate imaging during procedures.

Why it’s dangerous

The x-ray irradiation field can shift relative to the image display screen when the C-arm is positioned at certain angles. This shift might cause the system to show inaccurate images during medical procedures.

Who’s affected

Healthcare professionals using Canon's INFX-8000C X-ray systems with models CAS-880A or CAS-830B are most at risk. Patients receiving imaging during these procedures may also be affected.

How to tell if you have this one

Check for the model numbers CAS-880A or CAS-830B on the Canon INFX-8000C X-ray system. The recall applies to units sold in the U.S. by Canon Medical System, USA, INC.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify the model number on your system to confirm if it's CAS-880A or CAS-830B.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall indicates a potential for inaccurate imaging during procedures, but the risk of serious injury is not described in the official notice.

How do I know if my system is affected?

Check for model numbers CAS-880A or CAS-830B on your Canon INFX-8000C X-ray system.

What should I do if I have this system?

The official notice does not specify a remedy or action for affected units.

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-1175-2021 — Canon Medical Canon Medical

Hello,

I own a Canon Medical that is covered by recall Z-1175-2021 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-1175-2021 (February 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1175-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 System INFX-8000C

Lower-risk recall