BEUDAMED
    FDA Enforcement Class II Ongoing

    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

    Recall: Z-1802-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1802-2025
    Event ID
    96889
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    May 13, 2025
    Classification Date
    May 16, 2025
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

    Reason

    Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Code Info

    Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

    Quantity

    65 units (6 US, 59 OUS)