BEUDAMED
    FDA Enforcement Class II Ongoing

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    Recall: Z-1211-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1211-2026
    Event ID
    98111
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2026
    Initiation Date
    December 3, 2025
    Classification Date
    January 29, 2026
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. 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).

    Code Info

    MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045.

    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.

    Quantity

    5 units