{"recall":{"id":"fda-device-99834","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Philips North America recalls 12 products","firm":"Philips North America","date":"2026-08-28","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;","code":"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","number":"Z-3307-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3308-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3309-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3310-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3311-2026","classification":"Class II"},{"name":"MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;","code":"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","number":"Z-3312-2026","classification":"Class II"},{"name":"MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;","code":"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","number":"Z-3313-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3314-2026","classification":"Class II"},{"name":"SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;","code":"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","number":"Z-3315-2026","classification":"Class II"},{"name":"Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;","code":"Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;","quantity":"1","number":"Z-3316-2026","classification":"Class II"},{"name":"Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;","code":"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","number":"Z-3317-2026","classification":"Class II"},{"name":"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;","code":"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","number":"Z-3318-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99834","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e1b247b32b6e6740","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99834","record":[{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3307-2026","product_description":"Ingenia Blue Seal SE and Blue Seal XE;  Model number (REF): 1. 782185 (SE), 2. 782192 (XE);  Software Versions: R11, R12 and R13;","product_quantity":"6","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3308-2026","product_description":"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;","product_quantity":"216","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3309-2026","product_description":"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;","product_quantity":"243","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3310-2026","product_description":"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;","product_quantity":"422","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3311-2026","product_description":"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;","product_quantity":"340","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3312-2026","product_description":"MR 5300;  Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196;  Software Versions: R11, R12 and R13;","product_quantity":"131","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3313-2026","product_description":"MR 7700;  Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199;  Software Versions: R11, R12 and R13;","product_quantity":"107","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3314-2026","product_description":"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;","product_quantity":"200","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3315-2026","product_description":"SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Versions: R11, R12 and R13;","product_quantity":"5","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3316-2026","product_description":"Upgrade dStream;  Model number (REF): 782127;   Software Versions: R11, R12 and R13;","product_quantity":"1","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3317-2026","product_description":"Upgrade to MR 7700;  Model number (REF): 782130;   Software Versions: R11, R12 and R13;","product_quantity":"30","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99834","recalling_firm":"Philips North America","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2296","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-3318-2026","product_description":"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;","product_quantity":"91","reason_for_recall":"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.","recall_initiation_date":"20260828","center_classification_date":"20260925","report_date":"20261007","code_info":"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;","more_code_info":""}]}}