FDA-Device2016-07-13Class II
GE Healthcare, Discovery MR750w
GE Healthcare, LLC
Hazard
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.
Sold states
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 Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay
Affected count
471 (184 US; 287 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, Discovery MR750w
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2016Don't want to check this manually?
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