BEUDAMED
    FDA Recall Terminated

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    Recall: Z-0403-2018 · Initiated July 11, 2017

    Recall

    Recall Number
    Z-0403-2018
    Event Number
    78830
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 11, 2017
    Terminated
    July 2, 2019
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    Reason

    Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

    Action

    A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

    Distribution

    Worldwide distribution, including US nationwide.

    Quantity

    559 total