Philips North America: Philips Ingenia Ambition S With Mr Elastography (mre). 1. Model Number (ref): 781359. 2. Model Number (ref): 782108. 3. Model Number (ref): 782139

Philips Ingenia Ambition S MRI Recall Summary Philips is recalling three models of its Ingenia Ambition S MRI machines with MR Elastography capability due to a software issue that can produce inaccurate stiffness measurements when certain image settings are used together. The problem affects machines distributed worldwide, including across all U.S. states and dozens of other countries. This is a Class II recall, meaning the defect could cause serious health consequences but is unlikely to be fatal.

Recalling firm

Philips North America

Product

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

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/86ca0fe8-c02c-48f5-b347-67ac510df417