Philips North America recalls SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

Recall date

December 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1216-2026

FDA classification

Class II

Brand / firm

Philips North America

Sold / distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, Unit…

Why it was recalled

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.