FDAApril 14, 2026device
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
philips north americaphilipsphilips north
UPCs
008848380997460088483810867700884838115743
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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