FDA Medical Device · Z-3239-2026

Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);

Class II · Ongoing

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

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Affected lots / codes — check yours against this1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109; 2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399, 46400, 46201, 46202, 46220, 46225, 46352, 46310, 46234, 46205, 46207, 46209, 46211, 46214, 46215, 46226, 46228, 46235, 46237, 46239, 46240, 46241, 46282, 46281, 46297, 46304, 46317, 46354, 46212, 61010, 46206, 46362, 46393, 46348, 46217, 46289, 46233, 46353, 46213, 46218, 46222, 46384, 46224, 46265, 46286, 46390, 46263, 46307, 46387, 46403; 3. Model Numbers (REF): 782137(S); UDI-DI: 884838108615; Serial Numbers: 64004, 64008, 64024, 64028, 64031, 64046, 64047, 64002, 64003, 64009, 64013, 64034, 64045, 64050, 64030, 64029, 64049, 64051; 4. Model Numbers (REF): 781358(X); UDI-DI: 884838088115; Serial Numbers: 45107, 45142, 45145, 45216, 45241, 45284, 45121, 45257, 45154, 45193, 45253, 45106, 45131, 45259, 45298, 45300, 45302, 45313, 45330, 45344, 45345, 45349, 45352, 45359, 45360, 45363, 45367, 45368, 45370, 45371, 45372, 45377, 45378, 45381, 45390, 45391, 45394, 45396, 45397, 45409, 45410, 45411, 45412, 45416, 45417, 45419, 45421, 45428, 45432, 45434, 45435, 45437, 45439, 45442, 45443, 45444, 45446, 45447, 45448, 45450, 45451, 45456, 45459, 45461, 45463, 45467, 45469, 45470, 45471, 45473, 45474, 45476, 45480, 45265, 45293, 45369, 45159, 45374, 45040, 45065, 45070, 45260, 45319, 45000, 45039, 45047, 45080, 45109, 45137, 45188, 45210, 45262, 45339, 45139, 45025, 45031, 45114, 45151, 45160, 45176, 45248, 45274, 45276, 45282, 45392, 45438, 45441, 45138, 45041, 45046, 45050, 45061, 45064, 45066, 45076, 45077, 45102, 45118, 45141, 45149, 45163, 45170, 45185, 45189, 45211, 45212, 45224, 45250, 45268, 45272, 45280, 45281, 45314, 45323, 45332, 45340, 45295, 45122, 45123, 45169, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45354, 45267, 45085, 45311, 45312, 45156, 45157, 45292, 45009, 45181, 45217, 45289, 45348, 45362, 45219, 45094, 45180, 45067, 45183, 45393, 45408, 45426, 45081, 45095, 45376, 45058, 45140, 45294, 45042, 45195, 45197, 45242, 45350, 45174, 45165, 45382, 45158, 45177, 45153, 45088, 45111, 45128, 45134, 45218, 45002, 45010, 45027, 45051, 45068, 45082, 45087, 45124, 45133, 45147, 45161, 45164, 45178, 45237, 45238, 45245, 45247, 45261, 45269, 45277, 45296, 45315, 45321, 45322, 45337, 45338, 45343, 45353, 45355, 45356, 45357, 45364, 45414, 45429, 45155; 5. Model Numbers (REF): 782107(X); UDI-DI: 884838098336; Serial Numbers: 62016, 62189, 45525, 45551, 45546, 45590, 62158, 62180, 62103, 62104, 62106, 62107, 62108, 62109, 62110, 62111, 62112, 62113, 62114, 62115, 62117, 62118, 62119, 62120, 62122, 62124, 62125, 62126, 62127, 62132, 62133, 62138, 62142, 62162, 62163, 62164, 62167, 62170, 62173, 62176, 62187, 62196, 62200, 62201, 62202, 62203, 62204, 62209, 62210, 62211, 62213, 62216, 62223, 62225, 62226, 62227, 62228, 62230, 62232, 62239, 62243, 62244, 62245, 62247, 45555, 62130, 62018, 62087, 62091, 45568, 62207, 62219, 45523, 45536, 45542, 62214, 45540, 45577, 62046, 62100, 62139, 62217, 45566, 45562, 45567, 45587, 45595, 62012, 62029, 62031, 62128, 62154, 62155, 62166, 62184, 62190, 62205, 62206, 62240, 62254, 62255, 62256, 62264, 62265, 45596, 45599, 62021, 62186, 45594, 45528, 45529, 45538, 45560, 45564, 62024, 62041, 62047, 62048, 62070, 62084, 62137, 62179, 62168, 45501, 45511, 45516, 45517, 45518, 45556, 45565, 62017, 62039, 62090, 62236, 62231, 45554, 62145, 62146, 62224, 62258, 62259, 62260, 62261, 62262, 62263, 62266, 45520, 45583, 62066, 62212, 62038, 62156, 62157, 62215, 62140, 62188, 62148, 45544, 45579, 62035, 62050, 62058, 62059, 62061, 62062, 62065, 62071, 62097, 62134, 45524, 45550, 62042, 45521, 45600, 45504, 45531, 45563, 45570, 62026, 62152, 62183, 62208, 62218, 62241; 6. Model Numbers (REF): 782119(X); UDI-DI: 884838104129; Serial Numbers: 66002, 66001; 7. Model Numbers (REF): 782136(X); UDI-DI: 884838108608; Serial Numbers: 28514, 28576, 28569, 28502, 28536, 28567, 28588, 28613, 28585, 28533, 28544, 28573, 28615, 28629, 28555, 28504, 28516, 28517, 28524, 28531, 28537, 28563, 28575, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28554, 28635, 28636, 28506, 28509, 28565, 28581, 28625, 28628, 28638, 28527, 28550, 28586, 28604, 28616; 8. Model Numbers (REF): 782158(X); UDI-DI: 884838115699; Serial Number: 90017;
Recalling firm
Philips North America Llc, Cambridge, MA
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
596
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D…
Recall initiated
August 21, 2026
Classified
September 18, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3239-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →