Lower risk Medical device recall · FDA · Published September 2, 2025

Canon Medical SPOT Fluoro System Recall: X-ray Coverage Risk

Canon Medical recalls SPOT Fluoro digital radiography systems with specific serial numbers due to potential X-ray coverage issues when changing acquisition programs. Affected units may have partial X-ray coverage risks during certain operations.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0037-2026Medical device Canon Medical ›

Lower-risk 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.

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Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon Medical is recalling specific SPOT Fluoro digital radiography systems that could have partial X-ray coverage when changing acquisition programs. This risk may lead to incomplete imaging during procedures, but the issue only occurs with specific software changes and not in normal use. Read more at govinfonow.com/recall/51492-canon-medical-spot-fluoro-system-recall-x-ray-coverage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51492-canon-medical-spot-fluoro-system-recall-x-ray-coverage-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0037-2026

Cite this page

“Canon Medical SPOT Fluoro System Recall: X-ray Coverage Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51492-canon-medical-spot-fluoro-system-recall-x-ray-coverage-risk. Based on FDA recall #Z-0037-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0037-2026%22&limit=1).

The FDA announced on September 2, 2025, that Canon Medical recalled eight digital radiography/fluoroscopy systems due to a software defect in the SPOT Fluoro program. The hazard involves collimator blades and static images potentially covering the X-ray area incorrectly when acquisition programs are changed.

How to tell if you have it

Brand: Canon Medical
Serial Numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004

The hazard

According to the FDA, when the acquisition program is changed, the collimator returns to a default ROI position which may be larger than specified, leaving the X-ray area partially covered by a static image. This software problem occurs only if the SPOT Fluoro function is used.

Context

GovInfoNow's records show Canon Medical System, USA, INC. has had 26 other recalls since April 18, 2018. Recent similar product recalls include a GE Optima XR200amx Mobile Radiography System recall on June 5, 2026, and a Philips Allura Cardio Vascular-Allura Centron X-Ray System recall on June 17, 2026.

How to tell if you have this one

Check if your SPOT Fluoro system has serial numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify your SPOT Fluoro system's serial number against the list: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.

How this recall unfolded

Recall timeline

FDA published this recall 43 days after the firm started it.

Sep 2, 2025Firm started the recall
Oct 8, 2025FDA classified it Class II
Oct 15, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this a safety hazard?

This is a low-risk issue that could affect imaging accuracy but does not cause serious injury or death in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/51492-canon-medical-spot-fluoro-system-recall-x-ray-coverage-risk">Canon Medical SPOT Fluoro System Recall: X-ray Coverage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0037-2026 (September 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0037-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.