Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling Achieva 3.0T MRI machines with MR Elastography (model 781278) distributed worldwide because certain image reconstruction settings can produce inaccurate stiffness measurements, caused by the voxel size settings in the default scan protocol displaying incorrectly. This is a Class II recall affecting machines across all U.S. states and numerous countries including Canada, the United Kingdom, and many others.
- 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
- 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/e2ad1c23-b9c8-485c-bee2-236b6998f50f