fda_recall · device_recall · high

Philips North America — Class II recall: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7813…

Event date
2026-05-06 00:00:00Z
Observed
2026-07-09 22:52:48Z
Source ID
Z-1956-2026
Payload hash
c73a0dafb4f45ce86b9fc710…

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.

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

Philips North America — Class II recall: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7813… · Argus HQ