medical Class II Updated 2024-12-04

GE Medical Systems, LLC recalls Discovery MR750w 3.0T, whole body magnetic resonance scanner

Recalled Product

Discovery MR750w 3.0T, whole body magnetic resonance scanner


Hazard / Issue

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable
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