Canon Medical System, USA recalls 8 SPOT Fluoro digital radiography systems in the United States after a software defect could expose patients to unintended X-ray exposure. The issue occurs when the acquisition program changes and the default ROI causes the collimator and static image to partially cover the collimated area. Stop using the affected devices and follow manufacturer instructions for a
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
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Digital radiography/fluoroscopy system used for diagnostic and interventional angiography to image blood vessels in heart, brain, abdomen and lower extremities.
Software defect can cause default ROI misalignment, potentially exposing areas outside intended field or misreporting exposure area.
This recall is not part of a broader industry pattern.
High risk to patient exposure accuracy; facility downtime and service costs likely.
Model numbers on device label; recall notice with official list.
Remediation typically 4–8 weeks after verification.
Keep model numbers, serial numbers, dates of service, and all recall communications.
Model numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004. Sold in the United States. Sold date and price not specified in provided data. Quantity: 8 units. Manufacturer: Canon Medical System, USA. Recall date: 2025-09-02. Status: ACTIVE.
No specific injuries or incidents are described in the provided data. Hazard is categorized as HIGH.
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