BEUDAMED
    FDA Enforcement Class II Ongoing

    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    Recall: Z-0975-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0975-2024
    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 Ambition X (Product Number 781356) - 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 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031

    Distribution

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

    Quantity

    10