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Philips North America recalls Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number
Recalled May 6, 2026 · FDA recall Z-1965-2026 · Philips North America
Hazard
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. · FDA Class II
Units
6 units
Sold at
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, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
Description
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.
Product
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →