Philips North America: Philips Evolution Upgrade 3.0t With Mr Elastography (mre). 1. Model Number (ref): 782143. 2. Model Number (ref): 782162

Recall Summary Philips is recalling two models of Evolution 3.0T MRI machines with MR Elastography (MRE) capability because software settings can cause inaccurate stiffness measurements when certain image reconstruction parameters are used. The machines were distributed worldwide, including throughout the United States and numerous other countries. This is classified as a Class II recall, meaning there is potential for serious health consequences but not an immediate threat to life.

Recalling firm

Philips North America

Product

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

Reason

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.

Classification

Class II

Category

medical device recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-14

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar,...

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9edda99d-ea53-4ef2-be7e-2cd4be9eeacc