Canon Medical System, USA, INC.: Medical Device Recall in 2025 - (Recall #: Z-0037-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 2, 2025

Date Posted: October 15, 2025

Recall Number: Z-0037-2026

Event ID: 97589

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 8

Code Information:

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

Distribution Pattern:

U.S.

Voluntary or Mandated:

FDA Mandated