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Medium risk Medical DevicesClass II

Philips SmartPath dStream 3.0T MRI Recall

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

Updated December 3, 2025

Philips SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when exporting MR Elastography maps to a picture archiving system. This could lead to misinterpretation of imaging results used in clinical diagnosis.

Is the Philips North America recalled? Yes. This product was recalled by FDA on December 3, 2025. Details below.

What is recalled

Philips SmartPath to dStream for 3.0T MR systems (Product Code REF: 782145) with software versions R11.1 and R12.1.

Am I affected

You're affected if you operate or use a Philips SmartPath to dStream 3.0T MRI system (Product Code 782145) running software version R11.1 or R12.1, particularly when exporting MR Elastography stiffness maps to a PACS (Picture Archiving and Communication System).

What to do right now

Contact Philips North America immediately regarding this recall. Do not rely on exported MR Elastography stiffness values from affected systems until you receive guidance or a software update from the manufacturer.

The hazard

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Brands affected

Philips North America
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1215-2026
Classification
Class II
Recalled
December 3, 2025
Read the official notice

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