Official recall record
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is in
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-09-02
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Canon Medical System, USA, INC.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
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