FDAFDA · Food and drugs·Recall number Z-0518-2025
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Published December 4, 2024 · Recall initiated: October 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, LLC
- Distributor
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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