Z-0327-2026Class II

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7

Name: Z-0327-2026 VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7
Creator: Canon Medical System, USA, INC.
Published: 2025-10-16
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2025-10-16 / Open, Classified / root cause: design

FDA source

Canon Medical System, USA, INC. began a recall of VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7 on 2025-10-16. FDA classified it as Class II and gives the reason as "Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0327-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-16
Posted: 2025-10-24
Recalling firm: Canon Medical Systems USA, Inc.
Product: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
Root cause tag: design
FDA root cause: Device Design
Action: Cannon Medical began notifying consignees via email on about 10/16/2025. Consignees were instructed that a representative of Canon Medical Systems USA will contact them to schedule a time to replace the relevant parts. If the message "Gradient power supply error is displayed before the replacement is performed, immediately stop using the system and contact your service representative. Consignees were requested to complete and return the provided response form
Quantity in commerce: 2 units
Distribution: US distribution to Ohio and Nevada
Product codes and lots: CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0327-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0327-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code LNH

K243335Class IIVantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation / cleared 2025-01-07

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)