BEUDAMED
    FDA Enforcement Class II Ongoing

    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116

    Recall: Z-1829-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1829-2024
    Event ID
    94493
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 22, 2024
    Classification Date
    May 15, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116

    Reason

    Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

    Code Info

    UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.

    Quantity

    32 units