FDADecember 7, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
ge medical systems
UPCs
0000000114004900000001140050000001140050000001140046000001140047000002830011000004440046000001140086000001140092000001140153000001140158000001140159
Recall history
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