Philips North America: Philips Smartpath To Dstream For Xr And 3.0t With Mr Elastography (mre). 1. Model Number (ref): 781270. 2. Model Number (ref): 782113
Recall Summary Philips is recalling two models of SmartPath to dStream MRI machines (models 781270 and 782113) used for liver stiffness imaging because they may produce incorrect stiffness measurements when certain image reconstruction settings are used. The recall affects medical facilities nationwide in the US and in numerous countries worldwide.
- Recalling firm
- Philips North America
- Product
- Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
- 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/f8212fe6-afe4-4dcf-be4a-c41329b87c2d