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Class IIOngoing

Philips North America recalls 12 products

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

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.

Company
Philips North America
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).
Who’s 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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99834…

Products (12)

  1. Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;

    Codes/lots: 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: 6Recall no. Z-3307-2026Class II

  2. 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;

    Codes/lots: 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, Quantity: 216Recall no. Z-3308-2026Class II

  3. 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;

    Codes/lots: 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, 7Quantity: 243Recall no. Z-3309-2026Class II

  4. 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;

    Codes/lots: 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, 2907Quantity: 422Recall no. Z-3310-2026Class II

  5. 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;

    Codes/lots: 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, 6404Quantity: 340Recall no. Z-3311-2026Class II

  6. MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

    Codes/lots: 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, 691Quantity: 131Recall no. Z-3312-2026Class II

  7. MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;

    Codes/lots: 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, 680Quantity: 107Recall no. Z-3313-2026Class II

  8. 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;

    Codes/lots: 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,Quantity: 200Recall no. Z-3314-2026Class II

  9. SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;

    Codes/lots: 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: 5Recall no. Z-3315-2026Class II

  10. Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

    Codes/lots: Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;Quantity: 1Recall no. Z-3316-2026Class II

  11. Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;

    Codes/lots: 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: 30Recall no. Z-3317-2026Class II

  12. 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;

    Codes/lots: 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 Quantity: 91Recall no. Z-3318-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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