FDAFDA · Food and drugs·Recall number Z-0519-2025
SIGNA Architect AIR, 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)00195278283481(11)231214(21)CNARC2300080TJ, System ID 82427110161; UDI/DI (01)00195278283481(11)230519(21)CNARC2300027TJ, System ID 82427090471; UDI/DI (01)00195278283481(11)231116(21)CNARC2300072TJ, System ID 82427120353; UDI/DI (01)00195278283481(11)230830(21)CNARC2300051TJ, System ID 82427140303; UDI/DI (01)00195278283481(11)230515(21)CNARC2300026TJ, System ID 82427200210; UDI/DI (01)00195278283481(11)230809(21)CNARC2300046TJ, System ID 82427090487; UDI/DI (01)00195278283481(11)230816(21)CNARC2300048TJ, System ID 82427010214; UDI/DI (01)00195278283481(11)230719(21)CNARC2300040TJ, System ID 82427070331; UDI/DI (01)00195278283481(11)230904(21)CNARC2300052TJ, System ID 82427090477; UDI/DI (01)00195278283481(11)231102(21)CNARC2300068TJ, System ID 82427160409; UDI/DI (01)00195278283481(11)230722(21)CNARC2300041TJ, System ID 82427040320; UDI/DI (01)00195278283481(11)231120(21)CNARC2300073TJ, System ID 82427090470; UDI/DI (01)00195278283481(11)231009(21)CNARC2300060TJ, System ID 82427030219; UDI/DI (01)00195278283481(11)240104(21)CNARC2400002TJ, System ID 82427090488; UDI/DI (01)00195278283481(11)231207(21)CNARC2300078TJ, System ID 82427090469; UDI/DI (01)00195278283481(11)230918(21)CNARC2300056TJ, System ID 82427200214; UDI/DI (01)00195278283481(11)240131(21)CNARC2400008TJ, System ID 82427030223; UDI/DI (01)00195278283481(11)240113(21)CNARC2400005TJ, System ID 82427060120; UDI/DI (01)00195278283481(11)231109(21)CNARC2300070TJ, System ID 82427130176; UDI/DI (01)00195278283481(11)230920(21)CNARC2300057TJ, System ID 82427100480; UDI/DI (01)00195278283481(11)231010(21)CNARC2300061TJ, System ID 82427100491; UDI/DI (01)00195278283481(11)230729(21)CNARC2300043TJ, System ID 82427250136; UDI/DI (01)00195278283481(11)240116(21)CNARC2400006TJ, System ID 82427250132; UDI/DI (01)00195278283481(11)240110(21)CNARC2400004TJ, System ID 82427110160; UDI/DI (01)00195278283481(11)231026(21)CNARC2300066TJ, System ID 82427100496; UDI/DI (01)00195278283481(11)231204(21)CNARC2300077TJ, System ID 82427100504; UDI/DI (01)00195278283481(11)230508(21)CNARC2300024TJ, System ID 82427160403; UDI/DI (01)00195278283481(11)231221(21)CNARC2300081TJ, System ID 82427030207; UDI/DI (01)00195278283481(11)240102(21)CNARC2400001TJ, System ID 82427120364; UDI/DI (01)00195278283481(11)231019(21)CNARC2300064TJ, System ID 82427120360; UDI/DI (01)00195278283481(11)240127(21)CNARC2400007TJ, System ID 82427200224; UDI/DI (01)00195278283481(11)231030(21)CNARC2300067TJ, System ID 82427200207; UDI/DI (01)00195278283481(11)231016(21)CNARC2300063TJ, System ID 82427140310; UDI/DI (01)00195278283481(11)230818(21)CNARC2300049TJ, System ID 82427140317; UDI/DI (01)00195278283481(11)230911(21)CNARC2300054TJ, System ID 82427140308; UDI/DI (01)00195278283481(11)230913(21)CNARC2300055TJ, System ID 82427190195
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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