Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Enforcement
- Recall Number
- Z-2211-2025
- Event ID
- 97172
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 6, 2025
- Initiation Date
- June 30, 2025
- Classification Date
- July 30, 2025
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
Description
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
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.
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;
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.
632 units