Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Reason: 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.

Code information: Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838104129, (4) 00884838108608, (5) None; Serial Numbers: (1) 42202, 45000, 45002, 45008, 45009, 45010, 45011, 45023, 45024, 45025, 45026, 45027, 45028, 45029, 45030, 45031, 45032, 45033, 45034, 45035, 45036, 45037, 45039, 45040, 45041, 45042, 45043, 45044, 45045, 45046, 45047, 45048, 45049, 45050, 45053, 45054, 45055, 45056, 45058, 45060, 45061, 45062, 45064, 45065, 45066, 45067, 45068, 45070, 45072, 45073, 45075, 45076, 45077, 45078, 45080, 45081, 45082, 45084, 45085, 45086, 45087, 45088, 45089, 45090, 45091, 45092, 45093, 45094, 45095, 45096, 45097, 45098, 45099, 45100, 45102, 45105, 45106, 45107, 45108, 45109, 45111, 45112, 45113, 45114, 45115, 45116, 45118, 45119, 45120, 45121, 45122, 45123, 45124, 45127, 45128, 45129, 45131, 45132, 45133, 45134, 45136, 45137, 45138, 45139, 45140, 45141, 45142, 45144, 45145, 45146, 45147, 45148, 45149, 45151, 45152, 45153, 45154, 45155, 45156, 45157, 45158, 45159, 45160, 45161, 45162, 45163, 45164, 45165, 45168, 45169, 45170, 45174, 45176, 45177, 45178, 45180, 45181, 45183, 45184, 45185, 45186, 45187, 45188, 45189, 45190, 45191, 45192, 45193, 45194, 45195, 45197, 45203, 45204, 45205, 45207, 45210, 45211, 45212, 45215, 45216, 45217, 45218, 45219, 45220, 45222, 45224, 45227, 45228, 45229, 45231, 45235, 45237, 45238, 45241, 45242, 45243, 45244, 45245, 45246, 45247, 45248, 45249, 45250, 45252, 45253, 45257, 45259, 45260, 45261, 45262, 45264, 45265, 45267, 45268, 45269, 45272, 45274, 45276, 45277, 45278, 45279, 45280, 45281, 45282, 45284, 45289, 45290, 45292, 45293, 45294, 45295, 45296, 45300, 45302, 45311, 45312, 45313, 45314, 45315, 45316, 45317, 45319, 45320, 45321, 45322, 45323, 45328, 45330, 45332, 45333, 45335, 45337, 45338, 45339, 45340, 45342, 45343, 45344, 45345, 45348, 45349, 45350, 45352, 45353, 45354, 45355, 45356, 45357, 45359, 45360, 45362, 45363, 45364, 45367, 45368, 45369, 45370, 45371, 45372, 45374, 45376, 45377, 45378, 45379, 45381, 45382, 45390, 45391, 45392, 45393, 45394, 45395, 45396, 45397, 45398, 45399, 45406, 45407, 45408, 45409, 45410, 45411, 45412, 45414, 45416, 45417, 45419, 45421, 45423, 45426, 45428, 45429, 45432, 45434, 45435, 45437, 45438, 45439, 45441, 45442, 45443, 45444, 45446, 45447, 45448, 45450, 45451, 45456, 45459, 45461, 45463, 45467, 45469, 45470, 45471, 45473, 45474, 45476, 45480, (2) 45500, 45501, 45503, 45504, 45506, 45507, 45508, 45509, 45510, 45511, 45514, 45516, 45517, 45518, 45519, 45520, 45521, 45523, 45524, 45525, 45528, 45529, 45530, 45531, 45532, 45533, 45534, 45536, 45538, 45540, 45542, 45543, 45544, 45545, 45546, 45547, 45550, 45551, 45554, 45556, 45559, 45560, 45561, 45562, 45563, 45564, 45565, 45566, 45567, 45568, 45570, 45572, 45573, 45574, 45577, 45578, 45579, 45580, 45583, 45587, 45589, 45590, 45594, 45595, 45596, 45599, 45600, 62011, 62012, 62016, 62017, 62018, 62019, 62021, 62023, 62024, 62026, 62029, 62030, 62031, 62033, 62035, 62038, 62039, 62040, 62041, 62042, 62044, 62046, 62047, 62048, 62050, 62051, 62052, 62054, 62056, 62058, 62059, 62061, 62062, 62063, 62065, 62066, 62067, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62084, 62087, 62088, 62090, 62091, 62092, 62097, 62098, 62100, 62103, 62104, 62106, 62107, 62108, 62109, 62110, 62111, 62112, 62113, 62114, 62115, 62117, 62118, 62119, 62120, 62122, 62124, 62125, 62126, 62127, 62128, 62129, 62130, 62132, 62133, 62134, 62136, 62137, 62138, 62139, 62140, 62142, 62145, 62146, 62147, 62148, 62151, 62152, 62153, 62154, 62155, 62156, 62157, 62158, 62159, 62162, 62163, 62164, 62166, 62167, 62168, 62170, 62173, 62176, 62178, 62179, 62180, 62181, 62182, 62183, 62184, 62186, 62187, 62188, 62189, 62190, 62191, 62196, 62197, 62198, 62199, 62200, 62201, 62202, 62203, 62204, 62205, 62206, 62207, 62208, 62209, 62210, 62211, 62212, 62213, 62214, 62215, 62216, 62217, 62218, 62219, 62223, 62224, 62225, 62226, 62227, 62228, 62230, 62231, 62232, 62241, 62243, (3) 66001, 66002, (4) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28558, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28567, 28568, 28569, 28572, 28575, 28576, 28581, 28587, 28592, (5) 26500, 26501, 26503, 26504, 26505, 26506, 26507, 26508, 26509, 26510, 26511, 26512, 26513, 26514, 26515, 26517, 26518, 26519, 26520, 26521, 26524, 26525, 26526, 26527, 26528, 26529, 26530, 26531, 26532, 26535;

Distribution pattern: 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, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.