Ingenia Elition X, Magnetic Resonance System.
This recall is currently active, issued April 17, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- March 12, 2024
- Posted
- April 17, 2024
- Recall Number
- Z-1571-2024
- Quantity
- 448 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Patient support table floor plate may be incorrectly installed.
Distribution
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.
Lot / Code Info
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.
Root Cause
Process design
Action Taken
Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com.