The Recall Desk
HighFDA (Devices)·Z-0037-2026·Announced 2025-10-15

Canon Medical Digital Radiography System SPOT Fluoro Display Obstruction

Canon Medical's diagnostic fluoroscopy systems have a software issue where the SPOT Fluoro function can obstruct the diagnostic image display when the acquisition program is changed, partially covering the collimated imaging area with a static overlay.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a documented software malfunction affecting diagnostic image display. No injuries or illnesses have been reported. This represents a risk-of-harm product where patient harm has not yet been documented.

Plain-English summary

Canon Medical System, USA, INC. has issued a recall of eight digital radiography/fluoroscopy systems used for diagnostic and interventional angiography procedures. These systems are affected by a software issue in the SPOT Fluoro imaging function.

When the SPOT Fluoro function is first activated, the system selects a default region of interest (ROI) and positions the collimator blades accordingly, with a static image overlay placed around the ROI. When a facility manually adjusts the ROI, the collimator and overlay adjust as expected. However, when the acquisition program is changed, the system reverts the collimator to the default ROI position. If this default position is larger than the currently specified ROI, the static image overlay will partially cover the collimated area, potentially obscuring the diagnostic image.

The problem occurs only within the SPOT Fluoro software and will not occur if this function is not used. The issue affects systems with the following serial numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004. All affected systems were distributed in the United States.

The recalled product

Product
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Diagnostic Imaging / Fluoroscopy
Hazard
  • software-malfunction
  • display-obstruction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Serial Numbers: SZA2422001
  • SXA2432001
  • SUC23Z2014
  • BBF2392003
  • SUC2392013
  • SZA2422002
  • SXA2432002
  • SZA2442004.

Distribution

Distribution scope not specified by the agency.

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