Philips North America recall Z-3314-2026 · FDA Recalls

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Class IIDeviceOngoing

Philips North America

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;

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.

Details

Recall number: Z-3314-2026
Event ID: 99834
Recall initiated: Aug 28, 2026
Classified: Sep 25, 2026
Reported: Oct 7, 2026
Quantity: 200
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.
Initiated by: Voluntary: Firm initiated

Lot / 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;