BEUDAMED
    FDA Enforcement Class II Ongoing

    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    Recall: Z-0974-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0974-2024
    Event ID
    93737
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    January 6, 2022
    Classification Date
    February 2, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296, United States

    Description

    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    Reason

    Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

    Code Info

    UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030

    Distribution

    Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.

    Quantity

    2