FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Evolution Upgrade 1.5T MRI recalled for stiffness value errors in elastography maps
What this means
Philips Evolution Upgrade 1.5T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical diagnosis. Three units have been identified worldwide.
- Contact Philips if you operate an affected MRI system (product codes 782148 or 782116 with software R11.1 or R12.1)
- Do not rely on exported elastography stiffness maps until you receive guidance from Philips
- Request a software update or corrective action from Philips North America
The agency's original wording
Hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Intended for
Adults
Illnesses reported
None reported
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
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1204-2026Want us to check the next one for you?
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