Canon Medical System recalled eight digital radiography systems on September 2, 2025. The software issue may leave X-ray areas partially covered by static images. Users should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions
The recall involves eight models of Canon's digital radiography/fluoroscopy system. The affected serial numbers include SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, and SZA2442004. These devices were distributed in the U.S.
The SPOT Fluoro software may revert the collimator blades to a larger default ROI, partially obscuring the intended X-ray area. This issue arises during the acquisition program change, potentially leading to diagnostic errors.
Currently, no injuries or incidents have been reported in connection with this recall. However, the software defect poses a significant risk during use.
Stop using the device immediately. Follow the recall instructions provided by Canon Medical System. Contact your healthcare provider for further guidance.
For more information, contact Canon Medical System, USA, at their official website or the recall page.
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