FDA DeviceClass IINotable

FDA Recall: Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mode

Date: 2026-05-06
Brand: Philips North America
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

103 units

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