Philips North America recalls Ingenia Ambition S. Product Code
- Recalling company
- Philips North America
- Product
- Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
- Reason
- The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 3, 2025
- Reported
- Feb 4, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 1 unit
- Lot / codes
- MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.
- Company location
- Cambridge, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1209-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1209-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.