FDAMay 10, 2024device

MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

What to do

FDA enforcement status: Ongoing

Brands named

canon medical systemcanoncanon medical

UPCs

0498767010336004987670101632049876701024000498767010164904987670102615

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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