Canon recalls Radrex-i X-Ray System software version v5.00ER005 due to image transmission failures during radiography. Affected units display error messages repeatedly when using wireless flat panel detectors.
software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
Canon is recalling its Radrex-i X-Ray System software version v5.00ER005 because it causes repeated image transmission errors during radiography. This could lead to incomplete scans and unnecessary rework for medical staff.
The software malfunction causes the system to repeatedly display an error message when transmitting images from the wireless flat panel detector. Users must repeatedly select 'OK' to reacquire images, which can lead to incomplete scans and unnecessary rework during radiography procedures.
Medical facilities using the Radrex-i X-Ray System with software version v5.00ER005 are affected. Staff performing radiography with wireless flat panel detectors are most at risk of repeated image acquisition failures.
Check if your Radrex-i X-Ray System has software version v5.00ER005. The system may be identified by serial numbers listed in the recall notice (e.g., U8A1312001, U8B14Z2017).
Verify your system's software version by checking the device settings or documentation. The affected version is v5.00ER005.
The software version v5.00ER005 has a malfunction that causes repeated image transmission errors during radiography, requiring users to repeatedly select 'OK' to reacquire images.
Check if your Radrex-i X-Ray System has software version v5.00ER005. Affected units are identified by specific serial numbers listed in the recall notice (e.g., U8A1312001, U8B14Z2017).
The recall does not specify a remedy, so contact Canon Medical System, USA, INC. for guidance on updating the software or other solutions.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1958-2019 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1958-2019 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.
