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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Philips Ingenia Elition X MRI system recalled for stiffness value errors in elastography maps

Philips
OTHERNationwide distribution

Contact Philips if you operate Ingenia Elition X MRI

Philips Ingenia Elition X MRI systems with certain software versions (R11.1 and R12.1) may display incorrect stiffness values when MR elastography maps are exported to a PACS viewer. This could lead to misinterpretation of tissue stiffness measurements used in clinical diagnosis.

  • Check if your Ingenia Elition X system matches one of the affected product codes and serial numbers listed in the recall
  • If affected, contact Philips North America for a software update or instructions
  • Do not rely on exported elastography stiffness values from these systems until the issue is resolved
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
31 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2026

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