Potential component failure in the Gradient Coil could product smoke and/or fire.
Reason for recall: Potential component failure in the Gradient Coil could product smoke and/or fire. Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta Quantity: 48 units Lot/code info: Product No. 781261 & 781262; UDI-DI: (01)00884838068438(21)77008, (01)00884838068438(21)77016, (01)00884838068438(21)77018, (01)00884838068445(21)77032, (01)00884838068445(21)77034, (01)00884838068445(21)77035, (01)00884838068445(21)77038, (01)00884838068445(21)77040, (01)00884838068445(21)77041, (01)00884838068445(21)77046, (01)00884838068445(21)77049, (01)00884838068445(21)77050, (01)00884838068445(21)77054, (01)00884838068445(21)77056, (01)00884838068445(21)77058, (01)00884838068445(21)77059, (01)00884838068445(21)77061, (01)00884838068445(21)77062, (01)00884838068445(21)77065, (01)00884838068445(21)77066, (01)00884838068445(21)77067, (01)00884838068445(21)77071, (01)00884838068445(21)77072, (01)00884838068445(21)77074, (01)00884838068445(21)77075, (01)00884838068445(21)77078, (01)00884838068445(21)77081, (01)00884838068445(21)77083, (01)00884838068445(21)77084, (01)00884838068445(21)77087, (01)00884838068445(21)77093, (01)00884838068445(21)77094, (01)00884838068445(21)77097, (01)00884838068445(21)77100, (01)00884838068445(21)77101, (01)00884838068445(21)77106, (01)00884838068445(21)77109, (01)00884838068445(21)77110, (01)00884838068445(21)77111, (01)00884838068445(21)77119, (01)00884838068445(21)77120, (01)00884838068445(21)77121, (01)00884838068445(21)77124, (01)00884838068445(21)77126, (01)00884838068445(21)77129, (01)00884838068445(21)77130, (01)00884838068445(21)77131, (01)00884838068445(21)77137; Serial No. 77008, 77016, 77018, 77032, 77034, 77035, 77038, 77040, 7704
00884838068438, 00884838068445
Official record: FDA (Device enforcement) ↗
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