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Medium risk Drugs & MedicationsClass II

Philips North America Recall

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

Updated April 14, 2026

Philips North America is recalling Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.. 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.

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). 1. Model Number (REF): 782145.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Drugs & Medications
Recall ID
fda-Z-1966-2026
Classification
Class II
Recalled
April 14, 2026
Read the official notice

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