Z-0037-2026Class II

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography...

Name: Z-0037-2026 This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography...
Creator: Canon Medical System, USA, INC.
Published: 2025-09-02
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2025-09-02 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in... on 2025-09-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0037-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-02
Posted: 2025-10-08
Recalling firm: Canon Medical Systems USA, Inc.
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 8
Distribution: U.S.
Product codes and lots: Serial Numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0037-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0037-2026	Class II	Ongoing	FDA Mandated	2025-10-15	2025-10-08

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)