FDA-Device2025-11-05Class IIPROCESSING DEFECT
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US distribution to Ohio and Nevada
Affected count
2 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2026Want us to check the next one for you?
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