fda_recall · device_recall · high

Philips North America — Class II recall: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model N…

Event date
2026-05-06 00:00:00Z
Observed
2026-07-09 22:52:52Z
Source ID
Z-1965-2026
Payload hash
1f39fe52367526e4d8e3133b

Summary

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. Status: Ongoing.

Informational only. Not legal, financial, or medical advice.