FDAJune 6, 2018device

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 548...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, 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.

What to do

FDA enforcement status: Terminated

Brands named

ge medical systems

UPCs

831042039078309240392883144839290831046538978310895600283096535911830965362488311292399583112923777830963227118310508995585110163303

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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