FDAClass IINovember 5, 2025

Vantage Galan 3t. Cmsc recall

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

Why was Vantage Galan 3t. Cmsc recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

Product
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Recalling firm
Canon Medical System, USA, INC.
Quantity
2 units
Distribution
US distribution to Ohio and Nevada
Recall date
November 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls