FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Evolution Upgrade 3.0T MR system recalled for stiffness value errors in elastography maps
OTHERNationwide distribution
Contact Philips about Evolution Upgrade 3.0T MR system
Philips MR systems (Evolution Upgrade 3.0T, software versions R11.1 and R12.1) may display incorrect stiffness values when MR Elastography maps are exported to a PACS viewer system. This could affect the accuracy of imaging data used in clinical assessment.
- If your facility operates an affected Philips Evolution 3.0T system with software R11.1 or R12.1, contact Philips for guidance on verification or software updates
- Review any exported MRE stiffness maps generated with these software versions for potential value discrepancies
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
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2026Don't want to check this manually?
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