Philips SmartPath dStream MRE Recall
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Updated April 14, 2026
Philips SmartPath to dStream 3.0T MR Elastography systems can produce incorrect stiffness measurements when certain image settings are used together. This may affect the accuracy of diagnostic results.
Is the Philips North America recalled? Yes. This product was recalled by FDA on April 14, 2026. Details below.
What is recalled
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE), Model Number 782145.
Am I affected
You're affected if your medical facility operates a Philips SmartPath to dStream 3.0T MR Elastography system with Model Number 782145 and uses the default MRE scan protocol.
What to do right now
Contact Philips North America immediately to discuss whether your system is affected and to obtain guidance on corrected settings or software updates for your MR Elastography protocols.
The hazard
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1966-2026
- Classification
- Class II
- Recalled
- April 14, 2026
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