Lower risk Medical device recall · FDA · Published August 28, 2026

Philips Ingenia 3.0T MRI Scanner: Incorrect DTI Data Export Hazard

Philips recalls Ingenia 3.0T and 3.0T CX MRI scanners with model numbers 781342, 781377, 782103, and 781271 due to incorrect diffusion tensor imaging data exports that may cause inaccurate nerve pathway mapping in brain imaging software.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3309-2026Medical device Philips ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

Philips is recalling specific models of 3.0T MRI scanners because they export incorrect diffusion tensor imaging (DTI) data when using the Enhanced MR DICOM format. This can lead to inaccurate nerve fiber pathway mapping in third-party brain imaging software. Read more at govinfonow.com/recall/1449219-philips-north-america-recalls-ingenia-3-0t-and-3-0t.

Source Summary by GovInfoNow · govinfonow.com/recall/1449219-philips-north-america-recalls-ingenia-3-0t-and-3-0t · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3309-2026

Cite this page

“Philips Ingenia 3.0T MRI Scanner: Incorrect DTI Data Export Hazard.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449219-philips-north-america-recalls-ingenia-3-0t-and-3-0t. Based on FDA recall #Z-3309-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3309-2026%22&limit=1).

The FDA announced on 2026-08-28 that Philips North America is voluntarily recalling Ingenia 3.0T and 3.0T CX MRI scanners due to a software defect. The hazard involves incorrect diffusion directions in exported data, which prevents third-party software from correctly processing the information for tractography.

How to tell if you have it

Brand: Philips
Product: Ingenia 3.0T MRI Scanner
Model numbers (REF): 781342 (3.0T), 781377 (3.0T), 782103 (3.0T), 781271 (3.0T CX)
Software Versions: R11, R12 and R13
Units affected: 243

The hazard

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

Context

GovInfoNow's records show Philips North America has 30 other recalls on record since 2020-12-24. Other recent recalls of similar products include Philips Ingenia Elition X MRE Scanner Recall: Stiffness Value Errors (2026-04-14) and Philips Achieva 3.0T MRI Recalled: Software Issue May Terminate Scans (2026-08-21).

How to tell if you have this one

Check if your Philips Ingenia 3.0T or 3.0T CX MRI scanner has model numbers 781342, 781377, 782103, or 781271. The serial numbers listed in the recall record correspond to specific units distributed worldwide.

Brand
Philips
Category
Medical device

FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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	Product, codes & lots	Quantity
Z-3307-2026	Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;; 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;	6
Z-3308-2026	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;; 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;	216
Z-3309-2026	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;; 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;	243
Z-3310-2026	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;; 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;	422
Z-3311-2026	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;; 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;	340
Z-3312-2026	MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;; 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;	131
Z-3313-2026	MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;; 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;	107
Z-3314-2026	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;; 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;	200
Z-3315-2026	SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;; 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;	5
Z-3316-2026	Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;; Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;	1
Z-3317-2026	Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;; 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;	30
Z-3318-2026	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;; 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;	91

Based on the official FDA remedy

What to do — step by step

Check Scanner Model
Identify your scanner's model number by checking the label on the device or the documentation provided with it.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Aug 28, 2026Firm started the recall
Sep 25, 2026FDA classified it Class II
Oct 7, 2026Published in FDA’s Enforcement Report
Oct 13, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/1449219-philips-north-america-recalls-ingenia-3-0t-and-3-0t">Philips Ingenia 3.0T MRI Scanner: Incorrect DTI Data Export Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3309-2026 (August 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3309-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.