ClearanceBrief
Recall Z-3279-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging

GE Medical Systems, LLC

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 548

DateJun 6, 2018
StatusTerminated
ReasonGE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
Root causeNonconforming Material/Component
ActionGE Medical Systems notified customers on or about 06/06/2018 via a customer letter entitled "Urgent Medical Device Correction". The letter directed its customers to continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. Safety information included the following: WARNING: Place appropriate non-conductive padding between the patient and the bore wherever a portion of the body may come into contact with the magnet opening. CAUTION: Continuous patient observation and contact are required in all modes o
Quantity516 Units Total
DistributionWorldwide Distribution - US Nationwide and in the states of AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, WA, WI, and WY. and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belar
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K142085DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
Ge Medical Systems, LLC, Sep 26, 2014