Canon Medical recalls INFX-8000F X-ray systems that may display horizontal stripes causing incomplete exams or requiring re-scans. Affected units have specific UDI-DI and serial numbers.
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Canon Medical is recalling its INFX-8000F X-ray systems because internal board changes can cause horizontal stripes on images, potentially requiring re-scans or interrupting exams. This affects medical facilities using the system for imaging procedures.
The X-ray system's internal board was modified by VAREX, causing flat panel detectors to display horizontal stripes. This can interrupt exams or require patients to be re-scanned with another X-ray system.
Medical facilities using the INFX-8000F X-ray system are most at risk. Patients undergoing exams with this system may need re-scans if images show abnormalities.
Check for the UDI-DI code 04987670100208 and serial numbers BGE2292016 or BGE2362017 on the device. The system is designed for medical imaging procedures.
Look for horizontal stripes in X-ray images that may indicate the system is defective.
Reach out to Canon Medical for verification of your unit's status and next steps.
VAREX changed the manufacturing of the internal board, causing flat panel detectors to display horizontal stripes that may interrupt exams or require re-scans.
Check for horizontal stripes in images and contact Canon Medical for verification and next steps.
Affected units have UDI-DI code 04987670100208 and serial numbers BGE2292016 or BGE2362017.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1155-2024 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1155-2024 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.
