Philips North America: Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

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: 690 units Lot/code info: Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47021, 47022, 47023, 47024, 47025, 47026, 47027, 47028, 47029, 47030, 47032, 47033, 47034, 47035, 47037, 47038, 47039, 47040, 47041, 47043, 47044, 47045, 47047, 47048, 47049, 47050, 47051, 47052, 47053, 47054, 47056, 47057, 47058, 47059, 47060, 47061, 47062, 47063, 47064, 47065, 47066, 47067, 47068, 47070, 47071, 47072, 47074, 47075, 47077, 47078, 47080, 47081, 47082, 47083, 47084, 47085, 47088, 47089, 47090, 47091, 47092, 47093, 47094, 47095, 47096, 47097, 47098, 47099, 47173, 47174, 47175, 47176, 47177, 47183, 47184, 47185, 47187, 47188, 47189, 47190, 47192, 47193, 47194, 47195, 47196, 47197, 47198, 47199, 47200, 47202, 47203, 47204, 47205, 47206, 47207, 47208, 47209, 47210, 47211, 47215, 47216, 47219, 47220, 47221, 47222, 47225, 47226, 47227, 47230, 47231, 47233, 47237, 47242, 47244, 47245, 47248, 47251, 47252, 47253, 47254, 47255, 47258, 47260, 47262, 47264, 47268, 47269, 47270, 47271, 47272, 47274, 47275, 47276, 47278, 47279, 47280, 47281, 47282, 47283, 47284, 47286, 47288, 47289, 47290, 47291, 47292, 47294, 47297, 47298, 47299, 47301, 47302, 47303, 47304, 47305, 47306, 47307, 47309, 47310, 47311, 47312, 47313, 47314, 47315, 47316, 47322, 47323, 47324, 47325, 47328, 47329, 47330, 47331, 47332, 47333, 4733

UPC codes

00884838090040, 00884838098350, 00884838108622

Source

Official record: FDA (Device enforcement) ↗

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