BEUDAMED
    FDA Enforcement Class II Ongoing

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

    Recall: Z-1863-2024 · Reported May 29, 2024

    Enforcement

    Recall Number
    Z-1863-2024
    Event ID
    94508
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2024
    Initiation Date
    May 3, 2024
    Classification Date
    May 17, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

    Reason

    The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

    Code Info

    UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

    Quantity

    1 unit