BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0975-2024 · Initiated January 6, 2022

    Recall

    Recall Number
    Z-0975-2024
    Event Number
    93737
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    LNH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 6, 2022
    Posted
    February 2, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    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.

    Action

    Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023.

    Distribution

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

    Quantity

    10