GE Medical Systems, LLC: SIGNA Architect AIR, 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: 3 units Lot/code info: 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)0019527

UPC codes

00195278283481, 82427110161, 82427090471, 82427120353, 82427140303, 82427200210, 82427090487, 82427010214, 82427070331, 82427090477, 82427160409, 82427040320, 82427090470, 82427030219, 82427090488, 82427090469, 82427200214, 82427030223, 82427060120, 82427130176, 82427100480, 82427100491, 82427250136, 82427250132, 82427110160, 82427100496, 82427100504, 82427160403, 82427030207, 82427120364, 82427120360, 82427200224, 82427200207, 82427140310, 82427140317, 82427140308, 82427190195

Source

Official record: FDA (Device enforcement) ↗

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