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Medium risk Medical DevicesClass II

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

Philips North America
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1966-2026
Classification
Class II
Recalled
April 14, 2026
Read the official notice

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