medical Class II Updated 2024-12-04

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

Recalled Product

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

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: 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)PG75M2300247SC, System ID 82427160390; UDI/DI To be provided, System ID 82427160408; UDI/DI To be provided, System ID 82427160402; UDI/DI To be provided, System ID 82427120372; UDI/DI To be provided, System ID 82427120357; UDI/DI To be provided, System ID 82427120351; UDI/DI (01)00840682147095(11)230700(21)PG75M2300253SC, System ID 82427150130; UDI/DI (01)00840682147095(11)240100(21)PG75M2400276SC, System ID 82427030222; UDI/DI (01)00195278283481(11)231113(21)CNARC2300071TJ, System ID 82427030218; UDI/DI (01)00840682147095(11)230600(21)PG75M2300248SC, System ID 83027009451123; UDI/DI (01)00840682147095(11)240200(21)ANTAT2400005TJ, System ID MR00169; UDI/DI (01)00840682147095(11)240200(21)ANTAT2400004TJ, System ID MR00168; UDI/DI (01)00840682147095(11)240100(21)ANTAT2400001TJ, System ID MR00185; UDI/DI (01)00840682122702(11)180223(21)PG75A1800019MR, System ID 850270540; UDI/DI To be provided, System ID 850270791; UDI/DI To be provided, System ID LV4001MR03; UDI/DI (01)00840682147095(11)230600(21)PG75M2300246SC, System ID MRUA2408; UDI/DI To be provided, System ID P00434MR01; UDI/DI To be provided, System ID RF3138MR01; UDI/DI To be provided, System ID RU1838MR04; UDI/DI To be provided, System ID RF3580MR01; UDI/DI To be provided, System ID SA1058MR05; UDI/DI (01)00840682147095(11)221100(21)PG75M2200180SC, System ID FEG88320; UDI/DI (01)00840682147095(11)230800(21)PG75M2300256SC, System ID DE492A99; UDI/DI To be provided, System ID NEV439249; UDI/DI To be provided, System ID 853270212; UDI/DI To be provided, System ID 853270202; UDI/DI (01)00840682147095(11)230300(21)PG75M2300227SC, System ID 853270223
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