Philips North America Llc recalls Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Num

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): 781315(1.5T); UDI-DI: 884838099715; Serial Numbers: 61019, 61140, 61080, 61067, 61091, 61114, 61028, 61039, 61040, 61041, 61000, 61002, 61003, 61006, 61009, 61017, 61032, 61058, 61065, 61066, 61074, 61075, 61097, 61106, 61124, 61001, 61004, 61011, 61023, 61025, 61026, 61034, 61035, 61042, 61046, 61115, 61078, 61015, 61119, 61005, 61020, 61043, 61085, 61088, 61036, 61052, 61057, 61061, 61068, 61069, 61070, 61072, 61095, 61117, 61125, 61126, 61129, 61130, 61027, 61108, 61109, 61131, 61144, 61107, 61138, 61142, 61102, 61103, 61014, 61018, 61016, 61038, 61073, 61079, 61082, 61084, 61092, 61093, 61096, 61022, 61044, 61049, 61050, 61053; 2. Model Numbers (REF): 781341(1.5T); UDI-DI: 884838055322; Serial Numbers: 87260, 70040, 70229, 70607, 70763, 84030, 84108, 84234, 84257, 84596, 87005, 87146, 70603, 70604, 70605, 70725, 70767, 70768, 70812, 70232, 70367, 70374, 70375, 70764, 70780, 84566, 84621, 84629, 84667, 87214, 87215, 70193, 70485, 70488, 70831, 70832, 70833, 70071, 70311, 84098, 84343, 84765, 70110, 70111, 70161, 70177, 70204, 70244, 70269, 70446, 70448, 70459, 70470, 70612, 70662, 70663, 70664, 70665, 70666, 70667, 70668, 70678, 70691, 70755, 70845, 70864, 70866, 70867, 70868, 70942, 70943, 70969, 84178, 84179, 84180, 84302, 84303, 84330, 84381, 84384, 84385, 84387, 84844, 84976, 87028, 87098, 87124, 87125, 87126, 87135, 87177, 87180, 87206, 87207, 87221, 87222, 87271, 87290, 87297, 84249, 84891, 70286, 70641, 70655, 70712, 70730, 70851, 84649, 84092, 84311, 84730, 84744, 84766, 84890, 84982, 84986, 87151, 87171, 87191, 70974, 70981, 70987, 70997, 84010, 84066, 84082, 84150, 84153, 84197, 84204, 84230, 84242, 84256, 84262, 84287, 84290, 84291, 84310, 84318, 84320, 84321, 84327, 84383, 84389, 84397, 84399, 84411, 84422, 84427, 84496, 84503, 84515, 84531, 84582, 84585, 84588, 84608, 84645, 84673, 84692, 84770, 84810, 84812, 84813, 84822, 84830, 84831, 84833, 84855, 84857, 84859, 84861, 84863, 84872, 84922, 84928, 84943, 84946, 84984, 84990, 84997, 87009, 87029, 87045, 87048, 87054, 87056, 87084, 87109, 87110, 87113, 87114, 87123, 87142, 87174, 87181, 87192, 87201, 87202, 87224, 87227, 87233, 87240, 87241, 87248, 87254, 87257, 87268, 87272, 87274, 87283, 87284, 87291, 87294, 87299, 87300, 87302, 87303, 87305, 87307, 87311, 87312, 87314, 87315, 87317, 87318, 87320, 87326, 87138, 84551, 70654, 84792, 87112, 84195, 70369, 70965, 70333, 70778, 84407, 84408, 84547, 84687, 70250, 70258, 84488, 87141, 84664, 70601, 87008, 70296, 70597, 70818, 70885, 70976, 70991, 84051, 84164, 84165, 84166, 84167, 84175, 84176, 84322, 84323, 84342, 84425, 84471, 84593, 84742, 87139, 87266, 84704, 84705, 70796, 84412, 70598, 84271, 84341, 84474, 84671, 84681, 84807, 84850, 84867, 84910, 84920, 84921, 87076, 70021, 70029, 70129, 70199, 70270, 70277, 70294, 70302, 70381, 70427, 70463, 70464, 70583, 70611, 70617, 70626, 70651, 70673, 70680, 70684, 70692, 70784, 70785, 70799, 70854, 70855, 70870, 70881, 70921, 70929, 70986, 70992, 70993, 84016, 84104, 84116, 84122, 84131, 84155, 84187, 84207, 84228, 84259, 84395, 84404, 84423, 84438, 84453, 84454, 84487, 84544, 84564, 84565, 84574, 84624, 84632, 84654, 84718, 84829, 84914, 84996, 87081, 87100, 87249, 87262, 84801, 84900, 84901, 70599, 70347, 70648, 70797, 84047, 84789, 87111, 70804, 84806, 70119, 70280, 70339, 70361, 70695, 70717, 70773, 70788, 70865, 70897, 70931, 70932, 70933, 70962, 70967, 84070, 84095, 84096, 84241, 84245, 84292, 84298, 84372, 84374, 84375, 84401, 84421, 84455, 84456, 84458, 84477, 84518, 84519, 84520, 84521, 84522, 84523, 84524, 84598, 84657, 84676, 84677, 84678, 84679, 84680, 84693, 84757, 84832, 84948, 84955, 87000, 87050, 87219, 87285, 87319, 84218, 70196, 70334, 70335, 70384, 70423, 70703, 70918, 70919, 84209, 84211, 84216, 84261, 84331, 84494, 84719, 84720, 87276, 87277, 87278, 87279, 87282, 87129, 87131, 87155, 87213, 87281, 70072, 70613, 70934, 70146, 70201, 70281, 70287, 70658, 84015, 87058, 70027, 70144, 70228, 70300, 70585, 70591, 70592, 70702, 70726, 70746, 70765, 70786, 70795, 70798, 70809, 70817, 70823, 70834, 70935, 70946, 70961, 84007, 84081, 84083, 84091, 84124, 84125, 84127, 84135, 84144, 84177, 84220, 84269, 84382, 84413, 84420, 84431, 84491, 84502, 84513, 84530, 84536, 84594, 84604, 84606, 84851, 84864, 84871, 84937, 84952, 84956, 84988, 84994, 84995, 87115, 87165, 87236, 70011, 70013, 70037, 70038, 70039, 70053, 70055, 70056, 70084, 70192, 70203, 70263, 70273, 70299, 70329, 70343, 70379, 70402, 70436, 70460, 70595, 70649, 70682, 70720, 70732, 70734, 70735, 70736, 70738, 70747, 70772, 70774, 70789, 70792, 70800, 70805, 70813, 70825, 70827, 70836, 70848, 70850, 70859, 70861, 70889, 70909, 70920, 70926, 70970, 84008, 84027, 84028, 84032, 84034, 84035, 84052, 84060, 84061, 84062, 84065, 84079, 84099, 84114, 84118, 84149, 84172, 84191, 84194, 84226, 84229, 84233, 84247, 84255, 84266, 84309, 84335, 84357, 84376, 84394, 84396, 84444, 84480, 84492, 84495, 84534, 84535, 84550, 84556, 84583, 84603, 84641, 84647, 84650, 84659, 84666, 84670, 84697, 84706, 84713, 84721, 84722, 84724, 84745, 84747, 84748, 84751, 84775, 84793, 84805, 84818, 84819, 84820, 84839, 84858, 84873, 84879, 84895, 84904, 84918, 84930, 84977, 87001, 87023, 87026, 87038, 87117, 87136, 87175, 87176, 87187, 87190, 87204, 87234, 87235, 87238, 87239, 87242, 87289, 87293, 84231, 84086, 84275, 84826, 84940, 87210, 70238, 70261, 70891, 84661, 84847, 87079, 84349, 84350, 84351, 84352, 84353, 84354, 84355, 84025, 84347, 70128, 70198, 70593, 84490, 87212, 84772, 84854, 87036, 87037, 84716, 70318, 87296, 70930, 84068, 70264, 70708, 70908, 84013, 84089, 84199, 84221, 84250, 84368, 84430, 84571, 84572, 84600, 84602, 84700, 84834, 84862, 84885, 84983, 84443, 84852, 70777, 70262, 70637, 70679, 70714, 70910, 70998, 84138, 84140, 84217, 84278, 84398, 70075, 70947, 70960, 84115, 84148, 84587, 84752, 87143, 87144, 70131, 70481, 70628, 70722, 84145, 70136, 84045, 84046, 70048, 70065, 70066, 70255, 70711, 87078, 87269, 70282, 84611, 70828, 84057, 84288, 84424, 70022, 70371, 70437, 70775, 70830, 84029, 84363, 84573, 84605, 84689, 87003, 87102, 70236, 70271, 84067, 84709, 84113, 84888, 70416, 70945, 84129, 87116, 70140, 70337, 70350, 70351, 70357, 70368, 70401, 70428, 70449, 70486, 70487, 70489, 70490, 70624, 70683, 70686, 70744, 70745, 70811, 70840, 70847, 70900, 70954, 70985, 84021, 84039, 84069, 84097, 84142, 84171, 84198, 84244, 84279, 84305, 84361, 84362, 84428, 84599, 84626, 84637, 84653, 84662, 84717, 84726, 84729, 84738, 84758, 84759, 84796, 84865, 84931, 84934, 84975, 84989, 87024, 87031, 87069, 87071, 87147, 87152, 87153, 87154, 87161, 87172, 87185, 87188, 87208, 87211, 87237, 87244, 87265, 87280, 70194, 70242, 70314, 70697, 70776, 70806, 70871, 70888, 84087, 84258, 84472, 84613, 84746, 84798, 84802, 87035, 87044, 87049, 87082, 87090, 87093, 70759, 70685, 70733, 70915, 84933, 70429, 70982, 84557, 70025, 70434, 70689, 70802, 84402, 84577, 84675, 70123, 70226, 70235, 70251, 70295, 70364, 70383, 70435, 70629, 70656, 70844, 70890, 70927, 70973, 84004, 84224, 84312, 84313, 84332, 84371, 84437, 84546, 84554, 84576, 84584, 84592, 84663, 84740, 84773, 84774, 84896, 87004, 87034, 87039, 87119, 87134, 87253, 70026, 70952, 84470, 70074, 70114, 70306, 70623, 70754, 70869, 84084, 84268, 84315, 87027, 70058, 70426, 70468, 70791, 70849, 84036, 84037, 84616, 84633, 84651, 84827, 84828, 84868, 87226, 70230, 84206, 84214, 84308, 84416, 84479, 84482, 84558, 84620, 84656, 84808, 84809, 84848, 70356, 70358, 70359, 70677, 70057, 70080, 70087, 70097, 70157, 70610, 70693, 70810, 84002, 84003, 84074, 84237, 84239, 84338, 84339, 84367, 84483, 84767, 84849, 84913, 84915, 84960, 84969, 87022, 87086, 87087, 87094, 87095, 87158, 87163, 87259, 70239, 87209, 70085, 70160, 70246, 70348, 70349, 70407, 70723, 70873, 70917, 87101, 70148, 70191, 70297, 70301, 70316, 70440, 70453, 70465, 70482, 70587, 70608, 70770, 70843, 70872, 70887, 70899, 70906, 70914, 70994, 84005, 84038, 84137, 84154, 84208, 84210, 84252, 84293, 84297, 84306, 84325, 84334, 84346, 84377, 84406, 84445, 84690, 84838, 84869, 87083, 87194, 70044, 70049, 70052, 70063, 70076, 70095, 70156, 70190, 70200, 70233, 70292, 70298, 70308, 70312, 70321, 70328, 70403, 70451, 70455, 70606, 70614, 70621, 70627, 70636, 70646, 70650, 70675, 70676, 70694, 70698, 70699, 70700, 70706, 70709, 70719, 70727, 70729, 70752, 70762, 70771, 70779, 70783, 70808, 70819, 70835, 70857, 70863, 70874, 70892, 70893, 70894, 70898, 70903, 70911, 70939, 70951, 70972, 84012, 84026, 84043, 84063, 84075, 84077, 84088, 84134, 84147, 84157, 84168, 84170, 84173, 84174, 84189, 84196, 84200, 84225, 84264, 84274, 84280, 84282, 84283, 84286, 84314, 84316, 84340, 84344, 84400, 84410, 84432, 84434, 84439, 84440, 84441, 84446, 84460, 84462, 84469, 84475, 84481, 84484, 84485, 84498, 84499, 84505, 84506, 84508, 84509, 84514, 84526, 84537, 84538, 84552, 84614, 84627, 84644, 84646, 84674, 84734, 84741, 84791, 84799, 84811, 84816, 84821, 84823, 84824, 84836, 84866, 84889, 84894, 84911, 84929, 84935, 84942, 84970, 84973, 84993, 87017, 87019, 87043, 87055, 87057, 87097, 87103, 87120, 87132, 87133, 87218, 87231, 87245, 70179, 70883, 84251, 84284, 84776, 84777, 84778, 84779, 84780, 84781, 84782, 84783, 70657, 70154, 70710, 87232, 87247; 3. Model Numbers (REF): 781396(1.5T); UDI-DI: 884838009820; Serial Numbers: 41175, 41176, 41007, 41039, 41127, 41157, 41256, 41350, 41132, 41186, 41230, 41268, 41359, 41441, 41521, 41584, 41204, 41449, 41151, 41518, 41524, 41610, 41615, 41617, 41618, 41619, 41509, 41591, 41045, 41108, 41180, 41314, 41366, 41397, 41486, 41519, 41436, 41070, 41351, 41010, 41016, 41029, 41052, 41071, 41084, 41112, 41125, 41131, 41141, 41142, 41160, 41178, 41192, 41210, 41211, 41228, 41240, 41283, 41335, 41338, 41368, 41380, 41381, 41388, 41389, 41395, 41417, 41442, 41454, 41473, 41538, 41540, 41561, 41009, 41050, 41113, 41272, 41480, 41087, 41093, 41096, 41129, 41163, 41184, 41193, 41213, 41217, 41220, 41246, 41257, 41267, 41352, 41365, 41399, 41494, 41502, 41522, 41545, 41049, 41060, 41068, 41074, 41106, 41117, 41124, 41126, 41128, 41133, 41136, 41153, 41243, 41280, 41292, 41298, 41299, 41357, 41408, 41435, 41437, 41452, 41493, 41496, 41507, 41513, 41543, 41544, 41549, 41558, 41559, 41565, 41570, 41571, 41115, 41405, 41560, 41020, 41169, 41188, 41293, 41458, 41466, 41467, 41474, 41013, 41100, 41140, 41190, 41214, 41249, 41301, 41450, 41461, 41304, 41075, 41562, 41164, 41219, 41296, 41331, 41394, 41111, 41594, 41407, 41476, 41477, 41479, 41003, 41162, 41172, 41185, 41191, 41254, 41255, 41498, 41515, 41138, 41259, 41440, 41531, 41329, 41478, 41146, 41318, 41355, 41371, 41376, 41423, 41453, 41548, 41000, 41006, 41015, 41021, 41022, 41028, 41035, 41037, 41044, 41048, 41057, 41059, 41066, 41067, 41077, 41083, 41092, 41094, 41095, 41097, 41098, 41134, 41148, 41149, 41154, 41158, 41166, 41171, 41195, 41197, 41198, 41203, 41205, 41206, 41208, 41209, 41212, 41221, 41222, 41237, 41250, 41251, 41260, 41265, 41278, 41290, 41294, 41305, 41313, 41358, 41406, 41409, 41415, 41418, 41420, 41421, 41426, 41429, 41463, 41481, 41482, 41495, 41511, 41512, 41514, 41517, 41525, 41532, 41551, 41552, 41555, 41569, 41580, 41224, 41238, 41319, 41526, 41118; 4. Model Numbers (REF): 782101(1.5T); UDI-DI: 884838098275; Serial Numbers: 87602, 87644, 87645, 87648, 87649, 87653, 87601, 87605, 87298, 87607, 87608, 87609, 87610, 87612, 87613, 87614, 87617, 87627, 87631, 87632, 87633, 87634, 87635, 87636, 87638, 87639, 87640, 87641, 87642, 87643, 87654, 87655; 5. Model Numbers (REF): 782115(1.5T); UDI-DI: 884838099043; Serial Numbers: 61250, 61281, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61213, 61214, 61280, 61299, 61341, 61292, 61358, 61385, 61266, 61201, 61210, 61212, 61217, 61227, 61350, 61403, 61417, 61264, 61273, 61192, 61193, 61246, 61206, 61208, 61219, 61248, 61249, 61265, 61269, 61328, 61337, 61257, 61425, 61303, 61306, 61316, 61320, 61321, 61348, 61349, 61354, 61355, 61356, 61357, 61360, 61378, 61404, 61419, 61420, 61421, 61332, 61175, 61181, 61182, 61183, 61188, 61199, 61200, 61204, 61218, 61220, 61224, 61268, 61270, 61289, 61295, 61300, 61334, 61338, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61400, 61408, 61409, 61410, 61411, 61413, 61422, 61428, 61177, 61180, 61184, 61185, 61187, 61189, 61191, 61205, 61209, 61221, 61222, 61225, 61229, 61230, 61237, 61243, 61245, 61253, 61262, 61263, 61275, 61279, 61313, 61314, 61315, 61336, 61288, 61352, 61416, 61179, 61258, 61359, 61304, 61380, 61145, 61196, 61381, 61426, 61407, 61415, 61427, 61232, 61223, 61298, 61195, 61226, 61351, 61333, 61339, 61252, 61234, 61203, 61235, 61329, 61241, 61326, 61327, 61176, 61198, 61202, 61211, 61240, 61256, 61283, 61285, 61290, 61293, 61294, 61302, 61406, 61207, 61233, 61242, 61282, 61331, 61342, 61383, 61384, 61310, 61311, 61312, 61259, 61260; 6. Model Numbers (REF): 782140(1.5T); UDI-DI: 884838108646; Serial Numbers: 45607, 45606, 45608, 45609, 45610, 45601; 7. Model Numbers (REF): 781261(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77008, 77000, 77004, 77001, 77019, 77010, 77014, 77007, 77016; 8. Model Numbers (REF): 781262(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77131, 77070, 77124, 77144, 77172, 77074, 77048, 77178, 77031, 77134, 77050, 77051, 77060, 77194, 77034, 77037, 77038, 77057, 77072, 77075, 77078, 77084, 77085, 77086, 77092, 77101, 77110, 77156, 77157, 77111, 77119, 77167, 77183, 77185, 77187, 77188, 77195, 77196, 77198, 77199, 77202, 77052, 77053, 77054, 77055, 77056, 77064, 77065, 77066, 77067, 77068, 77069, 77105, 77125, 77126, 77135, 77136, 77137, 77138, 77139, 77148, 77141, 77030, 77032, 77033, 77036, 77042, 77043, 77044, 77049, 77059, 77061, 77071, 77083, 77087, 77088, 77090, 77091, 77093, 77097, 77100, 77106, 77107, 77115, 77118, 77120, 77121, 77128, 77155, 77161, 77162, 77190, 77140, 77201, 77166, 77045, 77063, 77109, 77117, 77123, 77147, 77113, 77168, 77169, 77122, 77154, 77046, 77130, 77062, 77039, 77040, 77114, 77127, 77160, 77150, 77041, 77193, 77203; 9. Model Numbers (REF): 781347(1.5T S); UDI-DI: 884838068421; Serial Numbers: 81003, 81050, 81051, 81090, 81111, 81151, 81010, 81028, 81030, 81035, 81063, 81106, 81093, 81105, 81116, 81004, 81009, 81011, 81017, 81018, 81019, 81020, 81023, 81024, 81031, 81037, 81041, 81055, 81056, 81060, 81064, 81070, 81074, 81078, 81112, 81115, 81118, 81122, 81138, 81139, 81140, 81146, 81147, 81153, 81156, 81158, 81175, 81184, 81013, 81044, 81005, 81007, 81040, 81047, 81059, 81167, 81170, 81171, 81008, 81108, 81148, 81133, 81164, 81001, 81026, 81086, 81079, 81014, 81061, 81065, 81085, 81091, 81092, 81032, 81043, 81129, 81131, 81149, 81155, 81162, 81165, 81172, 81084, 81087, 81088, 81094, 81095, 81127, 81132, 81174, 81157, 81176, 81071, 81052, 81067, 81038, 81179, 81185, 81117, 81173, 81154, 81025, 81097, 81045, 81075, 81076, 81077, 81096, 81114, 81124, 81126, 81145, 81159, 81152, 81029, 81034, 81042, 81049, 81058, 81080, 81113, 81123, 81128, 81137, 81178;