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

Hazard

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

Details from the source

Reason for recall: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan. Quantity: 8 units 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

UPC codes

82427240081, 00840682103817, 82427120136, 82427200092, 82427250061

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.