FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia Elition S MRI system recalled for stiffness value errors in elastography maps
What this means
Philips Ingenia Elition S MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS (Picture Archiving and Communication System). This could affect the accuracy of tissue stiffness measurements used in clinical evaluation. Five units worldwide have been identified.
- If you operate an affected Ingenia Elition S system (serial numbers 46002, 46243, 46292, 64034, or 64045), contact Philips support immediately
- Do not rely on exported MRE stiffness values from these systems until the issue is resolved
- Verify your system software version and serial number against the recall details
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
All ages
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
5 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1211-2026Want us to check the next one for you?
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