United StatesThe VANTAGE GALAN 3T MRI system (CMSC model MRT-3020/U7, model number MEXL-3020/B7; serial numbers B7A2462002 and B7A2522014) distributed in Ohio and Nevada is being recalled by Canon Medical System, USA, Inc. It was recalled because the 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's being recalled
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Recalling firm: Canon Medical System, USA, INC., Tustin, CA, United States.
How to identify it
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to Ohio and Nevada
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)