Medical device recalls Moderate risk

GE Healthcare, LLC recalls GE Healthcare, Discovery MR750w

Recall date
June 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2131-2016
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
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 Germany Hungary India I…

Why it was recalled

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.

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

What was recalled

GE Healthcare, Discovery MR750w

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