FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia 1.5T MRI recalled for stiffness value errors in elastography maps
What this means
Philips has recalled certain Ingenia 1.5T MRI systems with software versions R11.1 and R12.1. When MR Elastography stiffness maps are exported to a PACS viewer, the stiffness values may display incorrectly. This could affect the accuracy of diagnostic information viewed in those systems.
- If your facility operates an affected Ingenia 1.5T MRI system, contact Philips North America for instructions
- Check your system's software version (R11.1 or R12.1) and product code (781341 or 781396)
- Do not use exported MR Elastography stiffness maps in PACS until Philips provides guidance
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
10 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1206-2026Want us to check the next one for you?
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