GE Medical Systems, LLC: SIGNA Architect, Nuclear Magnetic Resonance Imaging System

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: 53 units Lot/code info: UDI/DI (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2; UDI/DI To be provided, System ID 1000005000; UDI/DI (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4; UDI/DI (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3; UDI/DI To be provided, System ID 301295AMR2; UDI/DI To be provided, System ID GON90303794; UDI/DI To be provided, System ID 215955HON3T; UDI/DI (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T; UDI/DI (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7; UDI/DI (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR; UDI/DI (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T; UDI/DI (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355; UDI/DI To be provided, System ID 82427100482; UDI/DI To be provided, System ID 82427140330; UDI/DI To be provided, System ID 82427040333; UDI/DI To be provided, System ID 82427200209; UDI/DI To be provided, System ID 82427050061; UDI/DI To be provided, System ID 82427080138; UDI/DI (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128; UDI/DI To be provided, System ID 82427200219; UDI/DI To be provided, System ID 82427080142; UDI/DI To be provided, System ID 82427230234; UDI/DI (01)00840682147095(11)231000(21)PG75M2300266SC, System ID 82427100499; UDI/DI To be provided, System ID 82427160405; UDI/DI To be provided, System ID 82427160407; UDI/DI (01)00840682147095(11)230600(21)P

UPC codes

00840682147095, 00840682122702, 82427160355, 82427100482, 82427140330, 82427040333, 82427200209, 82427050061, 82427080138, 82427150128, 82427200219, 82427080142, 82427230234, 82427100499, 82427160405, 82427160407, 82427160390, 82427160408, 82427160402, 82427120372, 82427120357, 82427120351, 82427150130, 82427030222, 00195278283481, 82427030218, 83027009451123

Source

Official record: FDA (Device enforcement) ↗

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