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Home › FDA recalls › Evolution Upgrade 3.0T. Product Code
CLASS II · ModerateFDA

Philips North America recalls Evolution Upgrade 3.0T. Product Code

📅 Dec 3, 2025 · 📍 Nationwide
Recalling company
Philips North America
Product
Evolution Upgrade 3.0T. Product Code (REF): 782143. 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): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225.
Company location
Cambridge, MA
Recall type
Voluntary: Firm initiated
Recall number
Z-1205-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1205-2026 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.