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Recall Observatory FDA recall evidence

Device product

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

Z-1966-2026

April 14, 2026

Class II

Product summary

Firm
Philips North America
Event
Event 98779
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1966-2026

Official wording

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.

Code information: 1. Model Number (REF): 782145. UDI: (01)00884838108684(21)17385. Serial Numbers: 17385.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.