fda_recall · device_recall · high

Philips North America — Class II recall: Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812…

Event date
2026-05-06 00:00:00Z
Observed
2026-07-09 22:52:50Z
Source ID
Z-1953-2026
Payload hash
0f8f351a9c624d977f162568

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.