Philips North America: Philips Smartpath To Dstream For 1.5t With Mr Elastography (mre). 1. Model Number (ref): 781260. 2. Model Number (ref): 782112
Recall Summary Philips is recalling two models of SmartPath to dStream MRI machines (models 781260 and 782112) used for liver stiffness imaging because certain image reconstruction settings can cause the stiffness measurements to be inaccurate. The recalled devices are distributed worldwide, including across all U.S. states and dozens of countries.
- Recalling firm
- Philips North America
- Product
- Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
- 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/6a9905fb-368c-45c6-9b01-3155dc9448e0