Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling its SmartPath to dStream 3.0T MRI system with MR Elastography (model 782145) because certain image reconstruction settings can produce incorrect stiffness measurements when used with Resoundant's algorithm. The issue affects units distributed worldwide, including all U.S. states and numerous countries. This is classified as a Class II recall, meaning the problem could cause adverse health effects but is not life-threatening.
- Recalling firm
- Philips North America
- Product
- Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
- 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/87790323-2307-4c78-8268-dbb1243f1c5f