BEUDAMED
    FDA Enforcement Class II Ongoing

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    Recall: Z-1842-2024 · Reported May 29, 2024

    Enforcement

    Recall Number
    Z-1842-2024
    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

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    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: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083 35022 35063 35074 35049 35035 35067 35004 35006 35011 35015 35016 35021 35050 35057 35061 35075 35076 35082 35085

    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

    35 units