Recall Z-0327-2026— Canon Medical System, USA, INC.

Name: FDA recall Z-0327-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-16

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2025-10-16. It names one FDA 510(k) clearance: K243335. Product: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.. Reason: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-16
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K243335 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation·cleared 2025-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.