Philips North America: Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

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: 1,467 units Lot/code info: Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71001, 71002, 71003, 71004, 71006, 71007, 71008, 71010, 71011, 71012, 71013, 71014, 71016, 71018, 71020, 71022, 71023, 71026, 71027, 71029, 71031, 71035, 71037, 71038, 71039, 71040, 71045, 71047, 71051, 71055, 71056, 71058, 71060, 71061, 71062, 71064, 71065, 71068, 71070, 71071, 71072, 71073, 71074, 71077, 71078, 71081, 71084, 71086, 71087, 71088, 71089, 71093, 71095, 71097, 71101, 71106, 71107, 71150, 71152, 71153, 71154, 71155, 71156, 71157, 71159, 71162, 71163, 71164, 71165, 71166, 71168, 71170, 71172, 71173, 71174, 71175, 71176, 71177, 71179, 71181, 71183, 71184, 71185, 71187, 71188, 71189, 71190, 71192, 71193, 71194, 71195, 71197, 71198, 71200, 71203, 71204, 71208, 71210, 71211, 71213, 71214, 71215, 71216, 71220, 71224, 71225, 71227, 71228, 71231, 71252, 71260, 71262, 71263, 71266, 71267, 71268, 71269, 71270, 71271, 71272, 71275, 71276, 71277, 71279, 71280, 71282, 71283, 71285, 71286, 71287, 71288, 71290, 71291, 71296, 71297, 71298, 71299, 71300, 71301, 71302, 71303, 71304, 71305, 71307, 71308, 71309, 71311, 71312, 71313, 71314, 71315, 71317, 71318, 71319, 71320, 71321, 71322, 71323, 71324, 71326, 71327, 71328, 71329, 71331, 71332, 71333, 71334, 71335, 71336, 71337, 71338, 71339, 71340, 71341, 71342, 71343, 71344, 71345, 71346, 71347, 71349, 71350, 71351, 71352, 71353, 71354, 71355, 71356, 71357, 71358, 71359, 71360, 71361, 7136

UPC codes

00884838055339, 00884838009813, 00884838098299

Source

Official record: FDA (Device enforcement) ↗

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