BEUDAMED
    FDA Recall 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 · Initiated October 11, 2013

    Recall

    Recall Number
    Z-0335-2014
    Event Number
    66601
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 11, 2013
    Posted
    November 15, 2013
    Terminated
    August 4, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    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.

    Action

    Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.

    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