Philips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
Philips is recalling SmartPath MRI software because it exports incorrect diffusion tensor imaging data, preventing correct processing by third-party tractography software.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The hazard is a data integrity issue that prevents correct processing by third-party software, rather than a direct physical injury or acute health threat.
Plain-English summary
Philips North America is recalling specific versions of the SmartPath software for MRI systems, including models for 1.5T, 3.0T, XR, and Ingenia Elition X scanners. The recall involves approximately 200 units distributed worldwide, including in the United States and numerous international markets.
The recall is due to a software defect where the export of diffusion tensor imaging (DTI) scans using the Enhanced MR DICOM format contains incorrect data regarding diffusion directions. This error prevents third-party software used for tractography, such as mapping nerve fiber pathways in the brain, from correctly processing the data for reconstruction.
Healthcare facilities using these specific software versions (R11, R12, and R13) should contact Philips for remediation. The issue affects the accuracy of data used in specialized brain mapping applications.
The recalled product
- Product
- 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…
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Software
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MRI Systems Recalled for Incorrect Diffusion Tensor Imaging Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips Upgrade dStream Software Recall for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
Same hazard · data integrity
See all →- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
- ModeratePhilips Recalls Ingenia MRI Systems Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07