Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall involving a medical device software parameter error. No reported illnesses, injuries, or hospitalizations are stated in the source text. The hazard is a potential calculation error in diagnostic imaging, which presents a risk of incorrect diagnostic results rather than imminent harm to patient safety.
Plain-English summary
Philips North America is recalling the SmartPath to dStream 3.0T MRI scanner with MR Elastography (Model Number REF 782145, Serial Number 17385) due to a software error affecting stiffness value calculations.
The defect occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This combination causes the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
This scanner was distributed worldwide, including throughout the US and to 46 countries. Affected healthcare facilities using this device with the implicated parameter settings may obtain incorrect stiffness values during magnetic resonance elastography scans.
Anyone with this device should contact Philips North America for guidance on software corrections or other remedial steps.
The recalled product
- Product
- Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
- Manufacturer
- Philips North America
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- HighSmartPath dStream 3.0T upgrades recalled over elastography stiffness errors
FDA (Devices) · 2026-02-04
- HighSmartPath dStream upgrades recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- HighSmartPath to dStream 3.0T Medical Device Recall for Software Error
FDA (Devices) · 2025-05-28
- ModeratePhilips SmartPath to dStream Medical Imaging Software Alignment Error
FDA (Devices) · 2025-05-28
- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07