Philips North America: Philips Ingenia 1.5t Cx With Mr Elastography (mre). 1. Model Number (ref): 781262

Recall Summary Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography (model 781262) because certain combinations of image reconstruction settings can produce inaccurate stiffness measurements during scans. The device is distributed worldwide, including throughout the United States and 50+ other countries. This is classified as a Class II recall, meaning the problem could cause incorrect medical results but is not immediately life-threatening.

Recalling firm

Philips North America

Product

Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

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/bc075fae-67b3-42d8-a3cf-412573bbe00b