Philips North America: Philips Smartpath To Dstream For 3.0t With Mr Elastography (mre). 1. Model Number (ref): 782145
Philips is recalling SmartPath to dStream MR Elastography systems (Model 782145) used in 3.0T MRI machines worldwide because certain image reconstruction settings can cause incorrect stiffness measurements. This issue affects medical facilities in the US and numerous countries internationally. The problem occurs when specific reconstruction parameters are used with Resoundant's algorithm, resulting in voxel size settings that display incorrectly in the default scan protocol.
- 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
- 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/3c9f245a-ba69-439c-ada7-228aa2e76556