BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

    Recall: Z-1922-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1922-2020
    Event ID
    85513
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 13, 2020
    Initiation Date
    April 6, 2020
    Classification Date
    May 6, 2020
    Termination Date
    September 16, 2022
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

    Reason

    The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

    Code Info

    Serial # 200044 Additional unit as off 5/22/20: 200026

    Distribution

    Worldwide distribution including one unit distributed to Iowa.

    Quantity

    2