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Z-3311-2026Class II

Philips North America

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Philips North America
Product type
Device
Status
Ongoing
Report date
2026-10-07
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.
Firm state
MA
Product quantity
340
Initiated by
Voluntary: Firm initiated
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.

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;

Code / lot 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;

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →