FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips SmartPath to dStream MR systems recalled for stiffness value errors in elastography maps
OTHERNationwide distribution
Check Philips MR system software version
Philips SmartPath to dStream MR imaging systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used for clinical assessment. Three units have been identified worldwide.
- If you operate a Philips SmartPath to dStream MR system, check your software version (R11.1 or R12.1)
- If your system matches, contact Philips North America for software updates or guidance
- Review recent exported elastography studies to ensure diagnostic accuracy
Hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Sold states
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, United Kingdom.
Affected count
3 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2026Don't want to check this manually?
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