BEUDAMED
    FDA Recall Terminated

    Brilliance iCT Computed Tomography X-ray system

    Recall: Z-1695-2015 · Initiated April 13, 2015

    Recall

    Recall Number
    Z-1695-2015
    Event Number
    71231
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 13, 2015
    Posted
    May 29, 2015
    Terminated
    October 1, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT Computed Tomography X-ray system

    Reason

    A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.

    Action

    Philips sent an Urgent - Field Safety Notice dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Healthcare is recommending to stop the use of your system until the X-ray tube mounting fasteners are replaced. In addition, a Philips Field Service Engineer (FSE) will service your system via a Mandatory Field Change Order (FCO 72800638). A Philips FSE will contact you to schedule this appointment. If you need any further information or support concerning this issue, please contact your local Philips representative or your local Philips Healthcare office. This notice has been submitted to the appropriate Regulatory Agency. Philips apologizes for any inconveniences this problem has caused your organization. For further questions please call (440) 483-7600.

    Distribution

    Internationally to the countries of China and Norway.

    Quantity

    2