BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Recall: Z-0335-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0335-2014
    Event ID
    66601
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    October 11, 2013
    Classification Date
    November 15, 2013
    Termination Date
    August 4, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Reason

    If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.

    Code Info

    Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.

    Distribution

    Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.

    Quantity

    9 units