Canon Medical recalls INFX-8000V X-ray systems with model CAS-880A/CAS-830B due to potential image shift at certain C-arm angles. Affected units may require correction to prevent imaging errors.
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Canon Medical is recalling its INFX-8000V X-ray systems (models CAS-880A and CAS-830B) because the x-ray field can shift relative to the display screen at some C-arm angles. This could lead to inaccurate imaging results if not corrected.
The x-ray irradiation field may shift relative to the image display screen when the C-arm is positioned at certain angles. This shift could cause the x-ray beam to target areas outside the intended imaging region, potentially leading to inaccurate diagnostic results.
Healthcare facilities using Canon INFX-8000V X-ray systems with models CAS-880A or CAS-830B are likely affected. Medical staff and patients using these systems may be at risk of inaccurate imaging results.
Check if your Canon INFX-8000V system has model numbers CAS-880A or CAS-830B. The recall applies to systems sold in the U.S. by Canon Medical System, USA, INC.
Identify your Canon INFX-8000V system's model number to confirm if it is CAS-880A or CAS-830B.
This recall applies to Canon INFX-8000V systems with model numbers CAS-880A or CAS-830B. Check your system model to see if you are affected.
The recall does not specify a remedy. Contact Canon Medical System, USA, INC. for guidance on potential corrections or alternatives.
The recall describes a risk of inaccurate imaging results, not physical injury. No specific safety hazards are mentioned in the record.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1174-2021 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1174-2021 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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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.