Philips North America: Philips Upgrade To Mr 7700 With Mr Elastography (mre). 1. Model Number (ref): 782130

Recall Summary Philips is recalling its MR 7700 MR Elastography upgrade (Model 782130) because certain image reconstruction settings can cause stiffness measurement errors in scan results. The device is affected worldwide, including throughout the United States and numerous other countries. This is classified as a Class II recall, meaning there is potential for adverse health effects but not an immediate serious threat.

Recalling firm

Philips North America

Product

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

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/4092536f-9aee-4832-85e2-5d29995095d2