GE Healthcare, LLC recalls MSK 1.5T Extreme MR Scanner, a diagnostic imaging device

Recall date

May 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1927-2016

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Po…

Why it was recalled

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device