Canon Medical recalls X-ray systems that may display horizontal stripes, causing exams to stop or requiring alternative imaging. 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 X-ray systems that may show horizontal stripes on images, which could stop an exam or require using another X-ray system. This affects medical facilities using the equipment for interventional procedures.
The X-ray flat panel detector may display horizontal stripes, causing the exam to stop or requiring the patient to be re-scanned with another X-ray system. This happens due to changes in the internal board manufacturing.
Medical facilities using Canon's X-ray systems for interventional procedures are most affected. Patients undergoing exams with these systems may need to switch to alternative imaging if images are abnormal.
Check for UDI-DI: 04987670100192 and serial number B1E22X2005 on the equipment. The system is used in interventional settings for radiographic and fluoroscopic studies.
Look for UDI-DI: 04987670100192 and serial number B1E22X2005 on the X-ray system.
The internal board changes caused the detectors to display horizontal stripes, which may stop an exam or require using another X-ray system.
The official recall notice does not specify a remedy or action for facilities.
Patients may need to switch to another X-ray system if images show horizontal stripes, but this is not a direct patient hazard.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1154-2024 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1154-2024 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.