BEUDAMED
    FDA Recall Terminated

    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

    Recall: Z-0522-2018 · Initiated November 1, 2017

    Recall

    Recall Number
    Z-0522-2018
    Event Number
    79004
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    November 1, 2017
    Terminated
    August 14, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

    Reason

    One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

    Action

    Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.

    Distribution

    One domestic and 1 foreign consignee ( Spain)

    Quantity

    2