Canon Medical recalls SPOT Fluoro digital radiography systems with specific serial numbers due to potential X-ray coverage issues when changing acquisition programs. Affected units may have partial X-ray coverage risks during certain operations.
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
Canon Medical is recalling specific SPOT Fluoro digital radiography systems that could have partial X-ray coverage when changing acquisition programs. This risk may lead to incomplete imaging during procedures, but the issue only occurs with specific software changes and not in normal use.
When the acquisition program is changed in the SPOT Fluoro system, the collimator returns to a default ROI position that may be larger than the specified one. This can cause the X-ray area to be partially covered by a static image, potentially leading to incomplete imaging during procedures.
Healthcare professionals using Canon SPOT Fluoro systems for medical imaging are most at risk. The recall applies to specific serial numbers used in diagnostic and interventional angiography procedures.
Check if your SPOT Fluoro system has serial numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.
Verify your SPOT Fluoro system's serial number against the list: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.
The recall is due to a software issue where changing the acquisition program can cause the collimator to return to a default ROI position that may be larger than specified, potentially leading to partial X-ray coverage.
This is a low-risk issue that could affect imaging accuracy but does not cause serious injury or death in normal use.
Check your serial number against the list: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0037-2026 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-0037-2026 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.
