Philips North America Llc: Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

Recall number

Z-3238-2026

Recalling firm

Philips North America Llc

Product

Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

Status

Open, Classified

Initiated

2026-08-21

Posted

2026-09-18

Terminated

not on file

Reason

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.

Root cause

Software design

Action

On August 24, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " To prevent this issue from occurring, o Use the standard 3D Vane scan protocol from the Philips Examcard Database, or o For custom 3D Vane scan protocols, use a maximum of 480 for the reconstruction matrix and use a maximum of 167 for the number of slices. " You may continue to use affected systems in accordance with their intended use. " Circulate this notice to all users or new owners of this device so that they are aware of the issues and associated hazard/harm. " Please retain this Urgent Medical Device letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issue (reference 2026-PD-MR-006).

Quantity

1447

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, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;

Lot, serial or model codes

1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, 71928, 71930, 71935, 71944, 71946, 71951, 71952, 71957, 71958, 71973, 71987, 71988, 85010, 85024, 85026, 85028, 85037, 85042, 85048, 85049, 85050, 85061, 85065, 85073, 85075, 85079, 85096, 85098, 85099, 85105, 85111, 85112, 85127, 85141, 85152, 85153, 85160, 85162, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85184, 85198, 85200, 85204, 85218, 85220, 85226, 85230, 85242, 85243, 85247, 85249, 85251, 85259, 85263, 85268, 85269, 85270, 85272, 85280, 85282, 85283, 85284, 85285, 85288, 85290, 85291, 85294, 85300, 85303, 85305, 85309, 85310, 85311, 85313, 85314, 85323, 85325, 85329, 85332, 85333, 85334, 85335, 85336, 85339, 85344, 85345, 85346, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85369, 85370, 85371, 85373, 85374, 85375, 85376, 85380, 85382, 85383, 85384, 85385, 85386, 85387, 85389, 85390, 85392, 85397, 85398, 85399, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85415, 85416, 85417, 85418, 85419, 85420, 85422, 85425, 85426, 85427, 85429, 85430, 85431, 85432, 85433, 85434, 85439, 85440, 85442, 85447, 85448, 85449, 85453, 85454, 85455, 85456, 85457, 85458, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, 71372, 71649, 71581, 71582, 71748, 85143, 71405, 71373, 85265, 71047, 71662, 71678, 71891, 85189, 71267, 71353, 71402, 71457, 85450, 85451, 71474, 71338, 71418, 71924, 71991, 85202, 85306, 71437, 71003, 71020, 71023, 71173, 71192, 71283, 71288, 71298, 71315, 71337, 71359, 71363, 71370, 71396, 71400, 71440, 71501, 71576, 71590, 71603, 71751, 71791, 71838, 71874, 85025, 85161, 85253, 85301, 85319, 85342, 85391, 71346, 71362, 71910, 71983, 85063, 85183, 85205, 85206, 85216, 85341, 71334, 71409, 71476, 85023, 71061, 71106, 71162, 71165, 71181, 71280, 71349, 71351, 71357, 71410, 71428, 71460, 71477, 71512, 71518, 71643, 71677, 71691, 71717, 71743, 71750, 71762, 71763, 71842, 71854, 71900, 71966, 71967, 85122, 85140, 85147, 85149, 85190, 85203, 85210, 85224, 85318, 71367, 71461, 71545, 85241, 85302, 85348, 85372, 85459, 71423, 71177, 71326, 71424, 71681, 71758, 71863, 71892, 85057, 85245, 85246, 85250, 85286, 71001, 71002, 71004, 71007, 71012, 71013, 71014, 71035, 71037, 71039, 71056, 71070, 71093, 71095, 71154, 71155, 71174, 71175, 71183, 71211, 71228, 71268, 71269, 71282, 71341, 71347, 71361, 71401, 71411, 71413, 71416, 71425, 71429, 71450, 71463, 71489, 71498, 71527, 71571, 71587, 71589, 71592, 71635, 71641, 71652, 71655, 71659, 71670, 71676, 71682, 71686, 71694, 71760, 71766, 71767, 71772, 71778, 71801, 71802, 71825, 71844, 71851, 71864, 71869, 71878, 71879, 71880, 71881, 71882, 71897, 71972, 71992, 85022, 85038, 85064, 85069, 85074, 85076, 85083, 85121, 85124, 85217, 85377, 85378, 85381, 85396, 85400, 71086, 71343, 71671, 71679, 85428, 71107, 85166, 71058, 71078, 71176, 71263, 71299, 71307, 71321, 71387, 71575, 71625, 71640, 71799, 71852, 85181, 85187, 85312, 85330, 85365, 71172, 71195, 71790, 71948, 71996, 85004, 85136, 85223, 85317, 85109, 71956, 85232, 85304, 85021, 71159, 71364, 71380, 71563, 71953, 71170, 71296, 71781, 85213, 71097, 71722, 71335, 71919, 85148, 85367, 71302, 85366, 71150, 71188, 71225, 71360, 71634, 71665, 71884, 85009, 71510, 71746, 85018, 71648, 85236, 85260, 85368, 71220, 71227, 71272, 71350, 71451, 71522, 71700, 85012, 85054, 85316, 85388, 85414, 71077, 71204, 71365, 71398, 85091, 71478, 71618, 71826, 71669, 71764, 71833, 71867, 71270, 71051, 71231, 71604, 71650, 71689, 71823, 71895, 85059, 85321, 85340, 71600, 71848, 71305, 71445, 71566, 71018, 71040, 71072, 71189, 71197, 71198, 71224, 71332, 71384, 71434, 71442, 71448, 71486, 71496, 71597, 71623, 71644, 71645, 71703, 71706, 71737, 71752, 71871, 85081, 85114, 85142, 71314, 71583, 71808, 71916, 71291, 71304, 71368, 71371, 71711, 71756, 71822, 71860, 71911, 71931, 71936, 85123, 85125, 85185, 85193, 71333, 71377, 71386, 71524, 71785, 71789, 71986, 85019, 85209, 85295, 85322, 71352, 71426, 71977, 85020, 71215, 71285, 71287, 71308, 71318, 71354, 71459, 71490, 71534, 85101, 71010, 71016, 71022, 71029, 71045, 71062, 71064, 71065, 71071, 71073, 71153, 71187, 71190, 71194, 71200, 71203, 71213, 71275, 71277, 71317, 71319, 71331, 71336, 71369, 71376, 71379, 71382, 71388, 71397, 71399, 71407, 71415, 71444, 71456, 71483, 71495, 71528, 71529, 71569, 71570, 71584, 71599, 71667, 71675, 71680, 71683, 71721, 71732, 71735, 71796, 71805, 71810, 71827, 71829, 71858, 71893, 71914, 71982, 85067, 85094, 85154, 85221, 85275, 85278, 85436, 71436, 85222, 71544; 2. Model Numbers (REF): 781377(3.0T); UDI-DI: 884838009813; Serial Numbers: 42175, 42190, 42221, 42231, 42283, 42291, 42339, 42439, 42466, 42186, 42147, 42171, 42183, 42206, 42213, 42448, 42243, 42251, 42280, 42326, 42343, 42362, 42367, 42380, 42398, 42436, 42444, 42445, 42446, 42452, 42453, 42454, 42458, 42459, 42463, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42560, 42561, 42565, 42570, 42042, 42239, 42178, 42041, 42092, 42005, 42013, 42015, 42021, 42027, 42028, 42061, 42073, 42081, 42082, 42090, 42097, 42107, 42130, 42138, 42141, 42143, 42145, 42216, 42279, 42292, 42315, 42044, 42089, 42232, 42272, 42026, 42047, 42110, 42146, 42191, 42192, 42285, 42364, 42407, 42426, 42136, 42137, 42199, 42275, 42014, 42056, 42074, 42093, 42095, 42103, 42112, 42115, 42121, 42128, 42133, 42161, 42162, 42179, 42203, 42205, 42222, 42233, 42237, 42245, 42249, 42252, 42253, 42257, 42260, 42261, 42262, 42263, 42278, 42282, 42289, 42300, 42309, 42314, 42331, 42333, 42337, 42345, 42347, 42349, 42361, 42378, 42383, 42392, 42412, 42420, 42421, 42422, 42432, 42442, 42428, 42087, 42120, 42170, 42201, 42267, 42401, 42449, 42294, 42019, 42390, 42451, 42135, 42209, 42008, 42236, 42353, 42355, 42455, 42256, 42043, 42438, 42265, 42321, 42018, 42012, 42065, 42079, 42132, 42134, 42176, 42303, 42338, 42399, 42419, 42264, 42131, 42204, 42055, 42220, 42358, 42413, 42001, 42006, 42034, 42036, 42038, 42040, 42045, 42050, 42052, 42053, 42067, 42068, 42076, 42083, 42096, 42099, 42100, 42101, 42102, 42111, 42116, 42117, 42119, 42123, 42150, 42152, 42169, 42177, 42180, 42185, 42214, 42229, 42240, 42241, 42242, 42247, 42266, 42274, 42286, 42298, 42307, 42328, 42334, 42356, 42365, 42368, 42370, 42389, 42400, 42429, 42077, 42066; 3. Model Numbers (REF): 782103(3.0T); UDI-DI: 884838098299; Serial Numbers: 85724, 85667, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85650, 85656, 85657, 85658, 85659, 85660, 85662, 85692, 85710, 85715, 85721, 85722, 85725, 85727, 85729, 85735, 85738, 85739, 85740, 85743, 85745.85746, 85747, 85748, 85749, 85756, 85696, 85620, 85608, 85614, 85755, 85672, 85673, 85674, 85720, 85730, 85732, 85762, 85693, 85619, 85718, 85600, 85607, 85616, 85617, 85707, 85613, 85611, 85612, 85615, 85703, 85719, 85666, 85664, 85700, 85643, 85644, 85761; 4. Model Numbers (REF): 781271(3.0T CX); UDI-DI: 884838068452; Serial Numbers: 78121, 78150, 78157, 78096, 78012, 78074, 78154, 78161, 78170, 78171, 78172, 78173, 78182, 78183, 78189, 78190, 78196, 78198, 78205, 78210, 78212, 78213, 78216, 78218, 78221, 78225, 78240, 78242, 78243, 78244, 78250, 78251, 78252, 78253, 78256, 78257, 78262, 78263, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78279, 78280, 78281, 78282, 78283, 78284, 78288, 78289, 78291, 78292, 78293, 78294, 78295, 78296, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 78078, 78224, 78098, 78003, 78065, 78070, 78076, 78081, 78087, 78097, 78099, 78101, 78104, 78107, 78126, 78149, 78151, 78181, 78206, 78219, 78264, 78064, 78106, 78187, 78000, 78007, 78010, 78015, 78018, 78019, 78021, 78023, 78029, 78031, 78032, 78038, 78039, 78043, 78048, 78049, 78051, 78062, 78068, 78072, 78082, 78083, 78084, 78088, 78089, 78091, 78095, 78100, 78109, 78111, 78117, 78127, 78129, 78132, 78133, 78139, 78140, 78155, 78203, 78207, 78214, 78222, 78223, 78011, 78013, 78014, 78034, 78044, 78046, 78047, 78058, 78060, 78066, 78071, 78073, 78075, 78077, 78086, 78092, 78102, 78110, 78118, 78120, 78128, 78135, 78137, 78138, 78141, 78142, 78158, 78162, 78164, 78180, 78188, 78193, 78194, 78209, 78215, 78227, 78232, 78234, 78247, 78254, 78255, 78261, 78277, 78290, 78297, 78298, 78299, 78326, 78337, 78004, 78030, 78059, 78156, 78249, 78026, 78022; 5. Model Numbers (REF): 782105(3.0T CX); UDI-DI: 884838098312; Serial Numbers: 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78536, 78537, 78539, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78567, 78570, 78571, 78573, 78574, 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78532, 78535, 78538, 78540, 78541, 78542, 78543, 78544, 78552, 78566, 78568;

510(k) numbers

["K183063","K193215","K251808"]

PMA numbers

not on file

Product code

LNH

Firm FEI

3016618143

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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