FDA-Device2016-06-15Class II
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
GE Healthcare, LLC
Hazard
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.
Sold states
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 Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom
Affected count
97
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2016Don't want to check this manually?
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