FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia 3.0T CX MRI system recalled for stiffness value errors in elastography maps
OTHERNationwide distribution
Contact Philips about your Ingenia 3.0T CX MRI system
Philips has recalled certain Ingenia 3.0T CX MRI systems (software versions R11.1 and R12.1) because stiffness values displayed in exported elastography maps may be inaccurate when viewed in a PACS (Picture Archiving and Communication System). This affects 6 units worldwide, primarily in the United States and Europe.
- If your facility operates an affected Ingenia 3.0T CX system, contact Philips North America immediately for guidance
- Do not rely on elastography stiffness values from exported maps until you receive instructions from Philips
- Check your system's serial number against the list provided by Philips to confirm whether you are affected
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
6 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1208-2026Don't want to check this manually?
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