Philips North America: SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

Hazard

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Details from the source

Reason for recall: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finl Quantity: 294 units Lot/code info: Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; UDI-DI: (1) 00884838095083, (2) 00884838098909, (3) 00884838105805; Serial Numbers: (1) 17006, 17172, 17204, 17206, 17212, 17215, 17222, 17237, 17239, 17240, 17242, 17245, 17246, 17247, 17250, 17260, 17264, 17265, 17266, 17268, 17269, 17274, 17283, 17284, 17286, 17290, 17292, 17299, 17302, 17308, 17309, 17313, 17321, 17326, 17339, 17342, 17344, 17352, 17353, 17356, 17357, 17360, 17366, 17367, 17369, 17375, 17378, 17386, 17388, 17389, 17398, 17399, 17406, 17415, 17416, 17425, 17428, 17429, 17434, 17436, 17440, 17447, 17459, 17464, 17466, 17468, 17473, 17490, 17491, 17493, 17495, 17499, 17508, 17509, 17514, 17516, 17517, 17524, 17533, 17536, 17544, 17546, 17550, 17556, 17559, 17564, 17565, 17569, 17570, 17572, 17580, 17589, 17590, 17594, 17615, 23002, 23026, 23030, 23033, 23034, 23036, 24006, 24012, 24013, 24018, 24020, 24022, 24023, 24025, 24036, 24047, 24055, 24058, 24075, 24076, 24087, 24090, 24095, 24098, 24108, 24109, 24110, 24111, 24117, 24124, 24133, 24134, 24143, 24145, 34032, 34036, 34037, 34058, 34060, 34067, 34076, 34080, 34083, 34090, 34096, 34107, 34111, 34142, 34145, 34152, 34154, 34211, 34221, 34223, 34233, 34236, 34246, 34249, 34250, 34261, 34292, 35027, 35031, 35032, 35040, 35043, 35044, 35046, 35047, 35048, 35052, 35053, 35056, 35060, 35073, 35078, 35087, 38001, 38004, 38005, 38006, 38013, 38015, 38020, 38023, 38026, 38032, 38037, 38038, 38040, 38041, 38062, 38063, 38065, 38071, 38076, 38084, 38089, 3810

UPC codes

00884838095083, 00884838098909, 00884838105805

Source

Official record: FDA (Device enforcement) ↗

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