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Open, Classified

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

FDA Recall Z-0327-2026 · Posted 2025-10-24

Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2025-10-16
Product Quantity2 units

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

US distribution to Ohio and Nevada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2025-01-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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