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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Philips dStream 3.0T MRI system recalled for stiffness value errors in elastography images

Philips
OTHERNationwide distribution

Check Philips dStream MRI elastography readings

Philips dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography images are sent to picture archiving systems (PACS). This affects the accuracy of tissue stiffness measurements used in clinical diagnosis.

  • If you operate an affected MRI system, contact Philips for software update or guidance
  • Verify your system software version matches R11.1 or R12.1
  • Review any elastography stiffness measurements taken on affected systems with your technical team
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
1 unit
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2026

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