Philips North America: Philips Achieva 1.5t With Mr Elastography (mre). 1. Model Number (ref): 781196. 2. Model Number (ref): 781296
Recall Summary Philips is recalling two models of its Achieva 1.5T MRI machines with MR Elastography technology due to potential errors in stiffness measurements when certain image settings are used together. The incorrect settings can result in voxel size values that are too small in the default scan protocol. This recall affects machines distributed worldwide, including throughout the United States and numerous other countries.
- Recalling firm
- Philips North America
- Product
- Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
- 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/36602041-03ab-4543-adf4-29170e7c3be8