Canon Medical recalls INFX-8000F X-ray systems with CAS-880A/CAS-830B models 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-8000F X-ray systems with specific 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 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 hit unintended areas of the body, potentially leading to inaccurate imaging results.
Healthcare facilities using Canon's INFX-8000F X-ray systems with CAS-880A or CAS-830B models are most likely affected. Patients and staff at these facilities face the highest risk of inaccurate imaging results.
Check if your Canon Medical INFX-8000F system has model numbers CAS-880A or CAS-830B. The recall applies to systems sold in the U.S. between 2018 and 2020.
Identify if your system has model numbers CAS-880A or CAS-830B.
This recall applies to Canon INFX-8000F systems with specific model numbers (CAS-880A or CAS-830B). Check your model to see if you're affected.
The recall does not specify a remedy, so contact Canon Medical directly for guidance on next steps.
The recall was issued for systems sold in the U.S. between 2018 and 2020, but the exact recall date isn't stated 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-1176-2021 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1176-2021 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.
