Philips North America recalls SmartPath to dStream for 1.5T
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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;
Lot / code information
- REF
- ): 781260 (1.5T)
- UDI
- 00884838095076
- Serial #
5479, 5490, 8057, 8118, 8260, 8330 — +40 moreShow all
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- REF
- ): 782112 (1.5T)
- UDI
- 00884838098886
- Serial #
- 12002, 21205, 21658, 30031, 32378, 32519, 33338; 3
- REF
- ): 782146 (1.5T)
- UDI
- 00884838108691
- Serial #
- 8935, 13013, 21202, 30308, 32570, 32634, 32679, 32683, 32750, 33074, 33479, 33611, 33714, 39040; 4
- REF
- ): 782165 (1.5T)
- UDI
- 00884838115767
- Serial #
- 21763, 22170, 32402, 32409, 32971, 33379, 33387, 33571, 39075, 72160, 72190; 5
- REF
- ): 782145 (3.0T)
- UDI
- 00884838108684
- Serial #
- 17377, 17385, 17435, 24010, 24062, 34256, 34282, 38059, 38118, 38127, 38170, 38251, 38278, 38294, 38295, 38302, 38336, 73002, 74004, 74007, 74030; 6
- REF
- ): 782164 (3.0T)
- UDI
- 00884838115750
- Serial #
- 34038, 34254, 34268, 38021, 38046, 38061, 38086, 38090, 38223, 38246, 74020, 74033; 7
- REF
- ): 781270 (XR and 3.0T)
- UDI
- 00884838095083
- Serial #
17239, 17246, 17264, 17269, 17283, 17299 — +47 moreShow all
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- REF
- ): 782113 (XR and 3.0T)
- UDI
- 00884838098909
- Serial #
- 17346, 17439, 24039, 24077, 24146, 34131, 34212, 35045, 35063, 35071, 38075, 38197, 38234, 38291; 9
- REF
- ): 782129 (XR and 3.0T)
- UDI
- 00884838105805
- Serial #
- 34055, 38195; 10
- REF
- ): 782118 (Ingenia Elition X)
- UDI
- 00884838099746
- Serial #
- 42072, 42098, 42194, 42298, 42301, 42329, 42340, 71019, 71025; 11
- REF
- ): 782144 (Ingenia Elition X)
- UDI
- 00884838108677
- Serial #
- 42062, 42105, 42323, 42346, 42363, 71087, 71504; 12
- REF
- ): 782163 (Ingenia Elition X)
- UDI
- 00884838115743
- Serial #
- 42299, 42354, 42404, 71390
Show 26 more code fieldsShow fewer
What the firm is doing
On August 28, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. To prevent the issue from occurring while Philips is developing the software solution, use the Classic DICOM transfer option for exporting DTI scans. 2. You may continue to use your system(s) in accordance with the intended use. 3. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. 4. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3314-2026
- FDA 510(k) clearance · K110151The device's official FDA premarket clearance record
- FDA 510(k) clearance · K213583The device's official FDA premarket clearance record
- FDA 510(k) clearance · K223458The device's official FDA premarket clearance record
- FDA 510(k) clearance · K251808The device's official FDA premarket clearance record
- FDA device classification · LNHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1000The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips North AmericaSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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