Official recall notice
Ingenia 3.0T and 3.0T CX Recall (Oct 2026) – Philips
Product: 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;
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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
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.
Affected products
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;