FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia 3.0T MRI system recalled for stiffness measurement errors
OTHERNationwide distribution
Contact Philips about your Ingenia 3.0T MRI system
Philips has identified a software issue in certain Ingenia 3.0T MRI systems that may cause incorrect stiffness values to appear when viewing elastography images on a PACS (picture viewing system). This affects 24 systems worldwide with specific software versions. No injuries have been reported.
- Check if your Ingenia 3.0T system has software version R11.1 or R12.1 and matches one of the listed serial numbers
- Contact Philips or your service representative to verify if your system is affected
- Do not rely on stiffness measurements from affected systems until Philips provides an update
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
24 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief