FDA-Device2018-10-31Class II
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
GE Medical Systems, LLC
Hazard
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
Sold states
Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.
Affected count
356 (98 US; 258 OUS)
Manufactured in
3200 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2019Don't want to check this manually?
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