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Z-3239-2026Class II

Philips North America Llc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Philips North America Llc
Product type
Device
Status
Ongoing
Report date
2026-09-30
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'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pak
Firm state
MA
Product quantity
596
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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.

Product description

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);

Code / lot info

1. 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;

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →