FDAFDA · Food and drugs·Recall number Z-2211-2025
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Published August 6, 2025 · Recall initiated: June 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- 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.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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