FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips Ingenia Ambition S. MRI system recalled for stiffness value errors
OTHERNationwide distribution
Contact Philips about your Ingenia Ambition S. system
Philips has recalled certain Ingenia Ambition S. MRI systems (software versions R11.1 and R12.1) because they may display incorrect stiffness values when MR Elastography images are sent to a PACS (picture viewing system). This could affect the accuracy of medical imaging data used for diagnosis.
- If your facility operates an Ingenia Ambition S. MRI system, contact Philips North America to determine if your device is affected
- Do not rely on exported MRE stiffness values until Philips confirms your device is unaffected or provides instructions
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
1 unit
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1209-2026Don't want to check this manually?
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