Philips North America: Philips Achieva 3.0t With Mr Elastography (mre). 1. Model Number (ref): 781278
Recall Summary Philips is recalling Achieva 3.0T MRI machines with MR Elastography (model 781278) distributed worldwide because certain image reconstruction settings can cause stiffness value measurement errors. The error occurs when specific parameters are combined with Resoundant's algorithm, resulting in incorrect voxel size display in the default scan protocol. This is a Class II recall affecting medical facilities in the US and numerous countries internationally.
- Recalling firm
- Philips North America
- Product
- Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
- 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/8885ea83-a4c2-4345-9143-a7db86712840