Philips North America: Philips Achieva 1.5t Initial System With Mr Elastography (mre). 1. Model Number (ref): 781178
Recall Summary Philips is recalling certain Achieva 1.5T MRI machines (Model 781178) because specific combinations of image reconstruction settings can produce inaccurate stiffness measurements when using MR Elastography technology. This affects units distributed worldwide, including throughout the United States and multiple other countries. This is classified as a Class II recall, meaning the problem could result in incorrect diagnostic information but is not an immediate safety threat.
- Recalling firm
- Philips North America
- Product
- Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
- 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/fdb4d0d4-b930-4fad-a379-a6ed7021aa8f