FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia Ambition X MRI system recalled for stiffness value errors in elastography maps
What this means
Philips has identified a potential error in how stiffness values are displayed when MR Elastography (MRE) images are exported to a PACS viewer on certain Ingenia Ambition X MRI systems. This affects 21 systems worldwide running software versions R11.1 or R12.1. The error could result in incorrect stiffness measurements being shown to clinicians.
- If you operate an Ingenia Ambition X MRI system, verify your software version (R11.1 or R12.1) and check your serial number against the FDA recall notice
- Contact Philips North America immediately if your system is affected
- Do not rely on exported MRE stiffness maps until you receive further guidance from Philips
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
21 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1210-2026Want us to check the next one for you?
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