FDA Device Recall Z-0037-2026: Canon Medical System, USA, INC.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0037-2026.

Recall Res Number

Z-0037-2026

Recalling Firm / Manufacturer

Canon Medical System, USA, INC.

FEI Number

2020563

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-09-02

Date Posted

2025-10-08

Date Terminated

N/A

Product Code

OWB

Event Number

97589

Product Quantity

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.

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.

Action Details 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.

Distribution Pattern U.S.

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

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Medical Device Recall: Z-0037-2026

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer