BEUDAMED
    FDA Recall Terminated

    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

    Recall: Z-1774-2021 · Initiated April 13, 2021

    Recall

    Recall Number
    Z-1774-2021
    Event Number
    87872
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 13, 2021
    Terminated
    September 23, 2022
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

    Reason

    Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

    Action

    Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.

    Quantity

    2 units (1 US and 1 OUS)