Official recall record

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144.

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

• 2025-06-30 · US FDA — Medical Devices
  SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
• 2025-05-13 · US FDA — Medical Devices
  Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
• 2024-09-03 · US FDA — Medical Devices
  SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a

Other recalls from this brand

• 2026-04-14 · US FDA — Medical Devices
  Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF):
• 2026-04-14 · US FDA — Medical Devices
  Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
• 2026-04-14 · US FDA — Medical Devices
  Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.