Philips North America: System, Nuclear Magnetic Resonance Imaging
Philips is recalling three models of its Evolution Upgrade 1.5T MRI machines with MR Elastography due to a software issue that can cause stiffness value errors when certain image reconstruction settings are used. The problem occurs because the voxel size settings in the default scan protocol display as too small when combined with Resoundant's algorithm. The recall affects machines distributed worldwide, including across all U.S. states and dozens of countries.
- Recalling firm
- Philips North America
- Product
- Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
- 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
- FDA-DEVICES
- Recall date
- 2026-04-14
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ce6633b7-be7b-4a8b-b16c-636093df7bbc