VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Summary
The FDA issued a Class II for VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. by Canon Medical System, USA, INC.. Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical.
Details
Source
Device Recall
External ID
Z-0327-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Lot/Code Info: CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Quantity Affected: 2 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.
Distribution
US distribution to Ohio and Nevada
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-16
Company
Tustin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Canon Medical System, USA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canon Medical System, USA, INC. have FDA actions?
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0327-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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