Philips North America Llc recalls Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 7

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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;