GE Medical Systems, LLC recalls GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex

Recalled October 31, 2018 · FDA recall Z-0553-2016 · GE Medical Systems

Hazard

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. · FDA Class II

Units

90 (54 US; 36 OUS)

Sold at

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.

Description

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.

Product

GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

Manufacturer(s)

GE Medical Systems, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →