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GE Healthcare, LLC recalls Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Recalled June 15, 2016 · FDA recall Z-1928-2016 · GE Healthcare
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. · FDA Class II
Units
101
Sold at
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
Description
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.
Product
Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →