Canon Medical System, USA, INC. recalls This device is a digital radiography/fluoroscopy system used in a diagnostic and inter…

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.

Letters prepared and emailed to notify the customer of the defect. The letter contains a return reply form that is to be completed by the customer and emailed to CMSU for retention.

• FDA enforcement recordOfficial FDA database entry for Z-0037-2026
• FDA 510(k) clearance · K210900The device's official FDA premarket clearance record
• FDA 510(k) clearance · K233107The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Canon Medical System, USA, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.