GE Healthcare, Discovery MR750w — recall Z-2131-2016
U.S. FDA — Device Enforcement · United States · 2016-06-08 · Class II
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germ
Reported risk: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is 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. No injury has been reported to GE as a result of this issue.
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