Class 2 Device Recall Ingenia Elition X

• Date Initiated by Firm: March 12, 2024
• Date Posted: April 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1571-2024
• Recall Event ID: 94233
• 510(K)Number: K193215 K213516 K213583
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Ingenia Elition X, Magnetic Resonance System.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Customer Care Solution Center; 1-800-722-9377
• Manufacturer Reason for Recall: Patient support table floor plate may be incorrectly installed.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 448 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH; 510(K)s with Product Code = LNH; 510(K)s with Product Code = LNH