Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-1571-2024)

Ingenia Elition X, Magnetic Resonance System.

Class II

Patient support table floor plate may be incorrectly installed.

Model No. 782136, 781358, 78217, 782119; UDI-DI 884838108622, 884838098336, 884838104129, 884838108608; Serial No. 45051, 45423, 45238, 45264, 45194, 45357, 45113, 45322, 45353, 45269, 45252, 45235, 45178, 45164, 45316, 45010, 45356, 45060, 45055, 45002, 45570, 45429, 45364, 45343, 45236, 45075, 45398, 45146, 45099, 45027, 45011, 45100, 45068, 45247, 45112, 45395, 66001, 45261, 45315, 45024, 45032, 45133, 45277, 45152, 45243, 45355, 45161, 45150, 45245, 45132, 45000, 45237, 45008, 45028, 45030, 45025, 45031, 45033, 45036, 45034, 45037, 45039, 45040, 45041, 45042, 45044, 45043, 45045, 45046, 45047, 45048, 45049, 45050, 45052, 45109, 45056, 45061, 45062, 45070, 45064, 45065, 45067, 45066, 45029, 45072, 45080, 45076, 45058, 45077, 45088, 45081, 45111, 45084, 45082, 45085, 45090, 45096, 45091, 45093, 45095, 45094, 45097, 45009, 45098, 45102, 45079, 45105, 45107, 45114, 45115, 45116, 45118, 45119, 45128, 45106, 45120, 45134, 45122, 45123, 45127, 45129, 45136, 45137, 45140, 45121, 45138, 45139, 45141, 45142, 45144, 45145, 45148, 45149, 45131, 45155, 45151, 45157, 45156, 45154, 45160, 45153, 45158, 45159, 45162, 45163, 45165, 45168, 45170, 45171, 45174, 45176, 45177, 45263, 45180, 45181, 45187, 45169, 45183, 45184, 45185, 45186, 45193, 45188, 45190, 45189, 45195, 45191, 45197, 45203, 45204, 45205, 45207, 45262, 45218, 45210, 45035, 45231, 45294, 45211, 45212, 45321, 45217, 45216, 45219, 45026, 45108, 45220, 45222, 45224, 45227, 45229, 45228, 45078, 45242, 45253, 45244, 45248, 45246, 45260, 45249, 45250, 45192, 45259, 45265, 45280, 45267, 45268, 45374, 45274, 45276, 45272, 45340, 45241, 45282, 45278, 45279, 45281, 45289, 45284, 45317, 45290, 45319, 45293, 45295, 45298, 45300, 45311, 45312, 45313, 45314, 45302, 45320, 45323, 45350, 45328, 45330, 45333, 45053, 45332, 45339, 45054, 45342, 45348, 45349, 45344, 45345, 45352, 45354, 45500, 45359, 45360, 45362, 45257, 45363, 45503, 45368, 45367, 45369, 45371, 45372, 45370, 45376, 45504, 45379, 45507, 45382, 45381, 45508, 45377, 45506, 45378, 45501, 45392, 45509, 45510, 45518, 45517, 45511, 45514, 45540, 45516, 45124, 45390, 45089, 45391, 45147, 45519, 45520, 45521, 45572, 45523, 45524, 45525, 45583, 45393, 45528, 45531, 45530, 45532, 45394, 45406, 45407, 45533, 45534, 45536, 45542, 45397, 45396, 45554, 45538, 45409, 45543, 45412, 45410, 45544, 45411, 45546, 45545, 45547, 45417, 45416, 45550, 45419, 45421, 45432, 45426, 45552, 45556, 45555, 45428, 45559, 45560, 45408, 45561, 45434, 45435, 45562, 45437, 45564, 45439, 45565, 45566, 45568, 45441, 45442, 45563, 45573, 45574, 45337, 45444, 45578, 45577, 45446, 45580, 45338, 45448, 45447, 45296, 45589, 45451, 45594, 45595, 45596, 62011, 62012, 45335, 45600, 45567, 45599, 62018, 62017, 45459, 62021, 45463, 45414, 62023, 62024, 45461, 62031, 62033, 45467, 62035, 45469, 62038, 62039, 62040, 62041, 62042, 62044, 45470, 62046, 62051, 62052, 62056, 45473, 62063, 62061, 45474, 62066, 62019, 62070, 62071, 45471, 45450, 62073, 45456, 62016, 62087, 62081, 62083, 62080, 62082, 45476, 62091, 45480, 62097, 62088, 62124, 62113, 62103, 62104, 62164, 62108, 62111, 45086, 62120, 62126, 62137, 62129, 45087, 62134, 62148, 62147, 62154, 62162, 62173, 62176, 66002, 28509, 28507, 28502, 62188, 62114, 62118, 62186, 62047, 62092, 62050.

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

Voluntary: Firm initiated