Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling two models of MRI imaging systems (SmartPath to dStream 1.5T) that may produce incorrect stiffness measurements when using certain image settings combined with specific reconstruction software. The error occurs because the default scan settings display voxel sizes that are too small, potentially affecting the accuracy of elastography results. The affected systems have been distributed nationwide in the US and in numerous countries worldwide.
- 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
- 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/1ebacf66-f859-4613-b761-93305a3acd34