FDAMarch 16, 2018device

ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

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

The hazard

Potential risk for helium gas inside the MR examination room during a magnet quench

What to do

FDA enforcement status: Terminated

Brands named

philips electronics north americaphilipsphilips electronics

Recall history

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

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