BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare Brilliance iCT computed tomography x-ray system

    Recall: Z-0331-2018 · Reported January 17, 2018

    Enforcement

    Recall Number
    Z-0331-2018
    Event ID
    78879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2018
    Initiation Date
    November 8, 2017
    Classification Date
    January 11, 2018
    Termination Date
    April 17, 2020
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Philips Healthcare Brilliance iCT computed tomography x-ray system

    Reason

    There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

    Code Info

    Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.

    Distribution

    107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts

    Quantity

    702