FDAMay 21, 2021device

Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of n...

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

The hazard

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

What to do

FDA enforcement status: Ongoing

Brands named

canon medical systemcanoncanon medical

Recall history

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

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Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of n... — Recall Details · AllClear