Philips SmartPath to dStream 3.0T MRE Recall: Stiffness Value Errors

The FDA announced on April 14, 2026, that Philips North America is voluntarily recalling one Philips SmartPath to dStream for 3.0T with MR Elastography unit due to potential stiffness value errors. The device may display incorrect reconstruction voxel size settings when specific image reconstruction parameters are used with Resoundant's algorithm.

How to tell if you have it

• Brand: Philips
• Product: Philips SmartPath to dStream for 3.0T with MR Elastography
• Model Number (REF): 782145
• UPC: 00884838108684
• Serial Number: 17385

The hazard

The recall addresses the potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This issue leads to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Context

GovInfoNow's records show Philips North America has issued 30 other recalls since December 24, 2020. Recent brand recalls include the August 28, 2026, recall of Evolution upgrade 1.5T and 3.0T models for incorrect diffusion tensor imaging data exports, and the July 31, 2026, recall of PIC iX Essentials Software due to patient information system freezes. Other recent recalls of similar products include the August 21, 2026, Philips Achieva 3.0T MRI recall for software issues that may terminate scans, and the December 3, 2025, Philips Incisive CT recall for unstable sensors causing incomplete scans.