Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling certain Evolution 3.0T MRI machines (models 782143 and 782162) distributed worldwide because they may produce inaccurate stiffness measurements when using specific image reconstruction settings with MR Elastography. The issue stems from incorrect voxel size settings in the default scan protocol. This is a Class II recall affecting medical facilities in the US and numerous countries worldwide.
- 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
- 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/c6fd9d9c-f063-40fe-a4b1-b4a2ef70151d