FDA · Class II · October 7, 2026

Philips recall: Ingenia Blue Seal SE and Blue Seal XE and 11 more products

Philips North America is recalling Ingenia Blue Seal SE and Blue Seal XE and 11 more products – 6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 28, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	Ingenia Blue Seal SE and Blue Seal XE and 11 more products
Brand	Philips
Company	Philips North America
Type	Medical devices
Classification	Class II
Recall date	August 28, 2026
Published by FDA	October 7, 2026
Quantity	6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91
Recall ID	99834

As listed by FDA

Recalled products (12)

Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
FDA recall number
Z-3307-2026
Codes, lots and dates
1. Model number (REF): 1. 782185 (SE); UDI-DI: 00884838125698; Serial Number: 53002; 2. Model Number (REF): 782192 (XE); UDI-DI: 00884838128422; Serial Numbers: 56000, 56001, 56005, 56010, 56012;
Quantity
6
Classification
Class II
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;
FDA recall number
Z-3308-2026
Codes, lots and dates
1. Model number (REF): 1. 781315 (1.5T); UDI-DI: 00884838099715; Serial Numbers: 61005, 61007, 61014, 61033, 61036, 61047, 61056, 61057, 61076, 61087, 61088, 61105, 61116; 2. Model Number (REF): 781341 (1.5T); UDI-DI: 00884838055322; Serial Numbers: 70042, 70051, 70056, 70062, 70203, 70227, 70229, 70249, 70257, 70262, 70285, 70300, 70311, 70383, 70424, 70432, 70438, 70445, 70453, 70460, 70472, 70588, 70598, 70619, 70638, 70642, 70645, 70647, 70708, 70717, 70724, 70728, 70743, 70750, 70751, 70787, 70801, 70821, 70825, 70836, 70846, 70875, 70876, 70886, 70889, 70896, 70904, 70920, 70957, 70961, 70967, 70970, 70979, 70988, 84049, 84076, 84079, 84080, 84141, 84162, 84170, 84173, 84186, 84205, 84212, 84219, 84233, 84250, 84254, 84266, 84267, 84281, 84289, 84329, 84332, 84335, 84343, 84359, 84360, 84368, 84379, 84388, 84392, 84403, 84415, 84431, 84433, 84436, 84450, 84451, 84467, 84476, 84491, 84500, 84510, 84539, 84549, 84555, 84556, 84568, 84596, 84634, 84635, 84641, 84642, 84652, 84660, 84708, 84713, 84714, 84721, 84741, 84745, 84768, 84804, 84839, 84840, 84853, 84858, 84867, 84869, 84893, 84904, 84908, 84978, 84987, 87068, 87076, 87092, 87196, 87197, 87259; 3. Model Number (REF): 781396 (1.5T); UDI-DI: 00884838009820; Serial Numbers: 41000, 41001, 41021, 41034, 41046, 41056, 41061, 41091, 41116, 41145, 41194, 41231, 41249, 41253, 41254, 41255, 41352, 41354, 41356, 41370, 41400, 41408, 41422, 41428, 41456, 41475, 41492, 41513, 41515, 41548; 4. Model Number (REF): 782115 (1.5T); UDI-DI: 00884838099043; Serial Numbers: 61186, 61191, 61196, 61219, 61228, 61236, 61238, 61272, 61276, 61317, 61382, 61383, 61384, 61386, 61387, 61388, 61390, 61396, 61399, 61401, 61402, 61408, 61411, 61418, 61430; 5. Model Number (REF): 782140 (1.5T); UDI-DI: 00884838108646; Serial Numbers: 45608, 45609; 6. Model Number (REF): 781262 (1.5T CX); UDI-DI: 00884838068445; Serial Numbers: 77047, 77058, 77059, 77120, 77143, 77151, 77158, 77161, 77179, 77180, 77182; 7. Model Number (REF): 781347 (1.5T S); UDI-DI: 00884838068421; Serial Numbers: 81027, 81033, 81145;
Quantity
216
Classification
Class II
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
FDA recall number
Z-3309-2026
Codes, lots and dates
1. Model number (REF): 1. 781342 (3.0T); UDI-DI: 00884838055339; Serial Numbers: 71001, 71002, 71008, 71031, 71038, 71051, 71061, 71072, 71084, 71088, 71089, 71095, 71101, 71154, 71163, 71164, 71166, 71184, 71185, 71193, 71210, 71231, 71269, 71271, 71288, 71290, 71297, 71301, 71303, 71309, 71311, 71312, 71322, 71335, 71336, 71340, 71341, 71344, 71355, 71375, 71385, 71393, 71412, 71413, 71420, 71422, 71427, 71438, 71441, 71443, 71445, 71446, 71449, 71450, 71459, 71462, 71463, 71475, 71486, 71487, 71489, 71491, 71513, 71521, 71528, 71556, 71558, 71562, 71589, 71604, 71607, 71612, 71615, 71619, 71620, 71639, 71641, 71646, 71665, 71673, 71688, 71697, 71704, 71710, 71715, 71729, 71730, 71739, 71754, 71756, 71757, 71759, 71813, 71817, 71828, 71831, 71841, 71849, 71850, 71853, 71862, 71885, 71896, 71921, 71923, 71954, 71959, 71960, 71962, 71963, 71964, 71986, 71992, 85006, 85020, 85032, 85038, 85046, 85066, 85068, 85076, 85078, 85085, 85087, 85091, 85092, 85102, 85126, 85148, 85150, 85154, 85191, 85201, 85216, 85245, 85279, 85377; 2. Model Number (REF): 781377 (3.0T); UDI-DI: 00884838009813; Serial Numbers: 42012, 42014, 42015, 42017, 42033, 42036, 42048, 42059, 42088, 42092, 42109, 42125, 42126, 42127, 42146, 42169, 42196, 42198, 42206, 42210, 42218, 42220, 42224, 42228, 42234, 42238, 42247, 42258, 42265, 42271, 42282, 42288, 42293, 42305, 42307, 42321, 42322, 42330, 42342, 42352, 42353, 42359, 42360, 42386, 42389, 42396, 42403, 42409, 42412, 42416, 42425; 3. Model Number (REF): 782103 (3.0T); UDI-DI: 00884838098299; Serial Numbers: 85646, 85652, 85679, 85686, 85708, 85723, 85758, 85759, 85762; 4. Model Number (REF): 781271 (3.0T CX); UDI-DI: 00884838068452; Serial Numbers: 78008, 78009, 78011, 78012, 78017, 78018, 78027, 78028, 78033, 78035, 78036, 78039, 78040, 78042, 78045, 78053, 78060, 78062, 78063, 78067, 78068, 78070, 78095, 78100, 78103, 78112, 78113, 78115, 78122, 78145, 78147, 78148, 78155, 78166, 78167, 78186, 78195, 78201, 78202, 78208, 78215, 78217, 78229, 78277, 78286, 78287;
Quantity
243
Classification
Class II
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
FDA recall number
Z-3310-2026
Codes, lots and dates
1. Model number (REF): 781359 (S); UDI-DI: 00884838090057; Serial Numbers: 48010, 48023, 48028, 48047, 48122, 48160, 48173, 48180, 48196, 48286; 2. Model Number (REF): 782108 (S); UDI-DI: 00884838098343; Serial Numbers: 48507, 48510, 48530, 48548, 48554, 48576, 48577, 48580, 48586, 48607, 48616, 48620, 48653, 48686, 48688, 48726, 48746, 48778, 48818, 48831, 48847, 48872, 48878, 48888, 48893, 48896, 48897, 48917, 48922, 48931; 3. Model Number (REF): 782139 (S); UDI-DI: 00884838108639; Serial Numbers: 29016, 29017, 29018, 29020, 29026, 29029, 29031, 29041, 29054, 29063, 29069, 29071, 29076, 29078, 29079, 29086, 29104, 29115, 29118, 29144, 29145, 29150, 29160, 29164, 29169; 4. Model Number (REF): 782159 (S); UDI-DI: 00884838115705; Serial Numbers: 91007, 91027, 91031, 91038, 91043, 91051; 5. Model Number (REF): 782194 (S); UDI-DI: 00884838128477; Serial Numbers: 22401, 22410; 6. Model Number (REF): 781356 (X); UDI-DI: 00884838090040; Serial Numbers: 47004, 47006, 47011, 47012, 47013, 47014, 47018, 47020, 47026, 47027, 47028, 47029, 47037, 47038, 47039, 47043, 47048, 47051, 47057, 47059, 47063, 47067, 47068, 47070, 47092, 47094, 47098, 47099, 47177, 47187, 47188, 47189, 47195, 47197, 47199, 47203, 47206, 47211, 47215, 47221, 47222, 47233, 47237, 47242, 47248, 47253, 47260, 47268, 47270, 47271, 47274, 47276, 47278, 47279, 47281, 47282, 47289, 47290, 47292, 47294, 47297, 47303, 47305, 47313, 47314, 47322, 47344, 47347, 47348, 47351, 47353, 47356, 47371; 7. Model Number (REF): 782109 (X); UDI-DI: 00884838098350; Serial Numbers: 47502, 47503, 47505, 47507, 47508, 47512, 47517, 47518, 47519, 47520, 47534, 47535, 47541, 47542, 47543, 47549, 47552, 47555, 47558, 47562, 47567, 47568, 47569, 47570, 47572, 47580, 47588, 47589, 47590, 47594, 47595, 47596, 47598, 47599, 47608, 47610, 47612, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47648, 47651, 47653, 47654, 47661, 47662, 47663, 47668, 47669, 47671, 47674, 47681, 47682, 47687, 47692, 47693, 47694, 47699, 47700, 47702, 47703, 47706, 47709, 47710, 47711, 47714, 47717, 47718, 47719, 47721, 47722, 47723, 47724, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47752, 47760, 47761, 47762, 47766, 47767, 47771, 47778, 47779, 47780, 47781, 47788, 47789, 47795, 47796, 47797, 47800, 47807, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47823, 47824, 47826, 47834, 47839, 47843, 47848, 47849, 47851, 47862, 47863, 47864, 47874, 47876, 47881, 47882, 47884, 47885, 47886, 47887, 47891, 47892, 47893, 47894, 47895, 47899, 47932, 47944, 47962; 8. Model Number (REF): 782138 (X); UDI-DI: 00884838108622; Serial Numbers: 49000, 49001, 49004, 49014, 49015, 49019, 49020, 49022, 49025, 49027, 49028, 49033, 49037, 49038, 49041, 49043, 49045, 49047, 49048, 49049, 49053, 49056, 49057, 49058, 49062, 49063, 49071, 49072, 49075, 49097, 49099, 49100, 49102, 49106, 49109, 49111, 49113, 49124, 49128, 49129, 49136, 49145, 49153, 49154, 49155, 49156, 49158, 49161, 49162, 49163, 49164, 49165, 49168, 49170, 49171, 49172, 49174, 49177, 49178, 49180, 49183, 49189, 49190, 49194, 49196, 49197, 49203, 49206, 49207, 49210, 49212, 49215, 49216, 49217, 49219, 49220, 49221, 49222, 49223, 49228, 49229, 49230, 49231, 49233, 49237, 49238, 49243, 49246, 49247, 49250, 49251, 49253, 49257, 49261, 49265, 49268, 49269, 49270, 49272, 49282, 49287, 49288, 49290, 49291; 9. Model Number (REF): 782160 (X); UDI-DI: 00884838115712; Serial Numbers: 92000, 92003, 92006, 92016, 92022, 92024, 92028, 92029, 92031, 92035, 92036, 92039, 92042, 92046, 92053, 92056, 92067, 92068, 92069, 92070, 92072, 92084, 92097; 10. Model Number (REF): 782195 (X); UDI-DI: 00884838128484; Serial Numbers: 55004, 55005, 55011, 55012, 55018, 55019, 55021, 55024, 55032;
Quantity
422
Classification
Class II
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
FDA recall number
Z-3311-2026
Codes, lots and dates
1. Model number (REF): 781357 (S); UDI-DI: 00884838088108; Serial Numbers: 46002, 46012, 46013, 46017, 46018, 46020, 46021, 46023, 46025, 46027, 46029, 46036, 46039, 46041, 46042, 46044, 46053, 46054, 46082, 46086, 46092; 2. Model Number (REF): 782106 (S); UDI-DI: 00884838098329; Serial Numbers: 46203, 46204, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46243, 46249, 46258, 46269, 46270, 46286, 46302, 46315, 46325, 46375; 3. Model Number (REF): 782137 (S); UDI-DI: 00884838108615; Serial Numbers: 64001, 64002, 64003, 64004, 64005, 64014, 64015, 64029, 64032, 64039, 64040, 64041, 64042, 64049, 64050, 64051, 64052; 4. Model Number (REF): 782157 (S); UDI-DI: 00884838115682; Serial Numbers: 8900, 89003; 5. Model Number (REF): 781358 (X); UDI-DI: 00884838088115; Serial Numbers: 45008, 45009, 45010, 45011, 45024, 45026, 45028, 45029, 45032, 45033, 45034, 45035, 45036, 45037, 45040, 45041, 45046, 45048, 45049, 45054, 45055, 45056, 45060, 45062, 45066, 45070, 45072, 45073, 45075, 45076, 45078, 45086, 45087, 45089, 45090, 45091, 45093, 45094, 45096, 45097, 45098, 45099, 45100, 45105, 45108, 45112, 45113, 45115, 45116, 45119, 45120, 45127, 45129, 45132, 45136, 45138, 45140, 45146, 45147, 45148, 45152, 45154, 45156, 45157, 45160, 45162, 45168, 45174, 45181, 45186, 45187, 45189, 45190, 45191, 45194, 45205, 45215, 45231, 45235, 45237, 45243, 45245, 45246, 45250, 45252, 45264, 45272, 45277, 45278, 45290, 45296, 45316, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45374, 45379, 45395, 45398, 45399, 45406, 45407, 45414, 45423, 45441; 6. Model Number (REF): 782107 (X); UDI-DI: 00884838098336; Serial Numbers: 45500, 45503, 45506, 45507, 45508, 45509, 45510, 45514, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45545, 45547, 45551, 45560, 45561, 45573, 45574, 45578, 45579, 45589, 45594, 62019, 62024, 62026, 62030, 62031, 62033, 62035, 62037, 62040, 62041, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62063, 62065, 62067, 62070, 62071, 62073, 62080, 62081, 62082, 62088, 62092, 62098, 62134, 62136, 62137, 62148, 62151, 62152, 62153, 62159, 62178, 62181, 62182, 62197; 7. Model Number (REF): 782119 (X); UDI-DI: 00884838104129; Serial Number: 66001; 8. Model Number (REF): 782136 (X); UDI-DI: 00884838108608; Serial Numbers: 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28521, 28524, 28525, 28526, 28527, 28528, 28529, 28532, 28533, 28535, 28536, 28538, 28540, 28542, 28543, 28544, 28546, 28547, 28548, 28549, 28550, 28555, 28558, 28559, 28560, 28563, 28564, 28565, 28566, 28568, 28572, 28573, 28576, 28577, 28579, 28581, 28583, 28585, 28586, 28587, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28604, 28605, 28608, 28611, 28612, 28613, 28614, 28615, 28616, 28618, 28619, 28623, 28625, 28628, 28629, 28630, 28631, 28632, 28635, 28636, 28638; 9. Model Number (REF): 782158 (X); UDI-DI: 00884838115699; Serial Numbers: 90001, 90002, 90004, 90006, 90007, 90010, 90011, 90015, 90016, 90017, 90018, 90023, 90024, 90027, 90036; 10. Model Number (REF): 782198 (X); UDI-DI: 00884838128460; Serial Numbers: 57003, 57004, 57005, 57009;
Quantity
340
Classification
Class II
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
FDA recall number
Z-3312-2026
Codes, lots and dates
1. Model number (REF): 782110; UDI-DI: 00884838099364; Serial Numbers: 63007, 63027, 63064, 63076, 63097, 63123, 63132, 63137, 63148, 63150, 63160, 63236, 63237, 63238, 63258, 63300, 63302, 63360, 63370, 63394, 63397, 63398, 63445, 63523, 63576, 63599, 63636, 63696, 63735, 63766, 63767, 63774, 63806; 2. Model Number (REF): 782152; UDI-DI: 00884838112841; Serial Numbers: 69000, 69007, 69008, 69012, 69015, 69016, 69017, 69030, 69048, 69067, 69068, 69070, 69071, 69076, 69078, 69089, 69094, 69096, 69097, 69101, 69102, 69110, 69121, 69124, 69126, 69128, 69134, 69135, 69137, 69143, 69150, 69154, 69160, 69161, 69171, 69175, 69180, 69193, 69194, 69198, 69209, 69212, 69238, 69239, 69240, 69241, 69247, 69249, 69250, 69263, 69264, 69265, 69266, 69287, 69289, 69290, 69299, 69300, 69304, 69307, 69309, 69310, 69312, 69316, 69318, 69319, 69320, 69321, 69338, 69342, 69344, 69345, 69366, 69367; 3. Model Number (REF): 782156; UDI-DI: 00884838115675; Serial Numbers: 93000, 93007, 93008, 93018, 93023, 93026, 93028, 93037, 93054, 93073, 93084, 93100, 93101, 93102, 93103, 93104, 93105, 93106; 4. Model Number (REF): 782196; UDI-DI: 00884838128446; Serial Numbers: 54016, 54024, 54036, 54040, 54050, 54054;
Quantity
131
Classification
Class II
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
FDA recall number
Z-3313-2026
Codes, lots and dates
1. Model number (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067; 2. Model Number (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68013, 68014, 68016, 68017, 68018, 68019, 68020, 68021, 68022, 68023, 68024, 68025, 68026, 68028, 68029, 68030, 68031, 68032, 68033, 68034, 68036, 68037, 68041, 68042, 68043, 68047, 68049, 68050; 3. Model Number (REF): 782155; UDI-DI: 00884838115668; Serial Numbers: 94000, 94002, 94004, 94006, 94007, 94008, 94009, 94011, 94012, 94013, 94014, 94015, 94016, 94021, 94023, 94024; 4. Model Number (REF): 782199; UDI-DI: 00884838128439; Serial Numbers: 19300, 19303, 19304, 19309, 19312, 19313;
Quantity
107
Classification
Class II
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X); Software Versions: R11, R12 and R13;
FDA recall number
Z-3314-2026
Codes, lots and dates
1. Model number (REF): 781260 (1.5T); UDI-DI: 00884838095076; Serial Numbers: 5479, 5490, 8057, 8118, 8260, 8330, 8392, 8819, 8884, 8954, 10044, 10170, 10236, 11062, 13018, 13029, 13047, 18663, 18872, 20033, 20115, 20164, 20319, 20322, 20413, 21011, 21062, 21133, 21142, 21156, 21278, 21577, 21583, 21621, 21775, 21880, 21969, 22157, 22248, 32049, 32245, 32262, 32286, 32322, 32845, 39024; 2. Model Number (REF): 782112 (1.5T); UDI-DI: 00884838098886; Serial Numbers: 12002, 21205, 21658, 30031, 32378, 32519, 33338; 3. Model Number (REF): 782146 (1.5T); UDI-DI: 00884838108691; Serial Numbers: 8935, 13013, 21202, 30308, 32570, 32634, 32679, 32683, 32750, 33074, 33479, 33611, 33714, 39040; 4. Model Number (REF): 782165 (1.5T); UDI-DI: 00884838115767; Serial Numbers: 21763, 22170, 32402, 32409, 32971, 33379, 33387, 33571, 39075, 72160, 72190; 5. Model Number (REF): 782145 (3.0T); UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 24010, 24062, 34256, 34282, 38059, 38118, 38127, 38170, 38251, 38278, 38294, 38295, 38302, 38336, 73002, 74004, 74007, 74030; 6. Model Number (REF): 782164 (3.0T); UDI-DI: 00884838115750; Serial Numbers: 34038, 34254, 34268, 38021, 38046, 38061, 38086, 38090, 38223, 38246, 74020, 74033; 7. Model Number (REF): 781270 (XR and 3.0T); UDI-DI: 00884838095083; Serial Numbers: 17239, 17246, 17264, 17269, 17283, 17299, 17356, 17357, 17369, 17406, 17416, 17425, 17434, 17464, 17468, 17473, 17514, 17544, 17550, 17564, 17565, 17569, 17589, 17590, 23026, 23033, 24006, 24012, 24023, 24066, 24075, 24087, 24090, 24108, 24110, 34107, 34152, 34154, 34233, 35032, 35047, 35054, 35056, 35087, 38001, 38004, 38023, 38071, 38084, 38089, 38120, 38202, 38300; 8. Model Number (REF): 782113 (XR and 3.0T); UDI-DI: 00884838098909; Serial Numbers: 17346, 17439, 24039, 24077, 24146, 34131, 34212, 35045, 35063, 35071, 38075, 38197, 38234, 38291; 9. Model Number (REF): 782129 (XR and 3.0T); UDI-DI: 00884838105805; Serial Numbers: 34055, 38195; 10. Model Number (REF): 782118 (Ingenia Elition X); UDI-DI: 00884838099746; Serial Numbers: 42072, 42098, 42194, 42298, 42301, 42329, 42340, 71019, 71025; 11. Model Number (REF): 782144 (Ingenia Elition X); UDI-DI: 00884838108677; Serial Numbers: 42062, 42105, 42323, 42346, 42363, 71087, 71504; 12. Model Number (REF): 782163 (Ingenia Elition X); UDI-DI: 00884838115743; Serial Numbers: 42299, 42354, 42404, 71390;
Quantity
200
Classification
Class II
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
FDA recall number
Z-3315-2026
Codes, lots and dates
1. Model number (REF): 782178; UDI-DI: 00884838122239; Serial Numbers: 42165, 42189, 71081; 2. Model Number (REF): 782207; UDI-DI: 00884838128576; Serial Numbers: 42055, 42287;
Quantity
5
Classification
Class II
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
FDA recall number
Z-3316-2026
Codes, lots and dates
Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;
Quantity
1
Classification
Class II
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
FDA recall number
Z-3317-2026
Codes, lots and dates
Model number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42002, 42030, 42037, 42066, 42104, 42151, 42163, 42164, 42211, 42219, 42248, 42376, 45001, 45007, 45043, 45044, 45052, 45179, 45236, 45263, 45552, 71060, 71262, 71279, 71406, 71532, 71565, 71580, 71616, 71907;
Quantity
30
Classification
Class II
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R11, R12 and R13;
FDA recall number
Z-3318-2026
Codes, lots and dates
1. Model number (REF): 782116 (1.5T); UDI-DI: 00884838099722; Serial Numbers: 41042, 41235, 41287, 41295, 41367, 41505, 41568, 70068, 70093, 70995, 70996, 84370; 2. Model number (REF): 782148 (1.5T); UDI-DI: 00884838108714; Serial Numbers: 41011, 41031, 41110, 41244, 41277, 41334, 41427, 41446, 41464, 41523, 41534, 70425, 70454, 70473, 70622, 70630, 70644, 70769, 70803, 70966, 70983, 84102, 84409, 84560, 84569, 84630, 84825; 3. Model number (REF): 782166 (1.5T); UDI-DI: 00884838115774; Serial Numbers: 41005, 41161, 41485, 41499, 41572, 70155, 70206, 70826, 84048, 84270, 84541; 4. Model number (REF): 782201 (1.5T); UDI-DI: 00884838128552; Serial Numbers: 84018, 84648; 5. Model number (REF): 782117 (3.0T); UDI-DI: 00884838099739; Serial Numbers: 42023, 42024, 42078, 42375, 71348, 85681, 85705; 6. Model number (REF): 782143 (3.0T); UDI-DI: 00884838108660; Serial Numbers: 42069, 42225, 42254, 42318, 42366, 42415, 42440, 71389, 71460, 71595, 71815, 71836, 85649, 85651, 85654, 85682, 85683, 85688, 85690, 85695, 85697, 85699, 85701, 85714; 7. Model number (REF): 782162 (3.0T); UDI-DI: 00884838115736; Serial Numbers: 42184, 42369, 71074, 71403, 71433, 71574, 71740, 85145;
Quantity
91
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99834
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Cambridge, MA, United States

Why it was recalled

The reason the FDA lists: “When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99834, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other Philips recalls

Date	Recall	Problem	Agency
Oct 7, 2026	Philips recall: Medical Systems Technologies LtdMedical devices · 62	an increased risk of a crash Serious	FDA Class II
Sep 30, 2026	Philips recall: Achieva 1.5T and 11 more productsMedical devices · 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965	A software issue will terminate an examination during the image reconstruction process if … Serious	FDA Class II
Sep 23, 2026	Philips recall: Patient Information Center iX REF:866389 and 1 more productMedical devices · 7359 Units; 312 units	Due to software malfunction, patient information system may freeze and become unresponsive… Serious	FDA Class II
Sep 9, 2026	Philips recall: Brilliance and 3 more productsMedical devices · N/A	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity… Serious	FDA Class II
Aug 26, 2026	Philips recall: Cardiac Workstation 5000 and 1 more productMedical devices · 796 units; 1,810 units	Device will intermittently provide inaccurate data related to native heart rate. Serious	FDA Class II

All 6 Philips recalls →

FAQ

About this recall

Is Philips Ingenia Blue Seal SE recalled?

Yes. Philips North America recalled it on August 28, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.