BEUDAMED
    FDA Recall Terminated

    Ingenuity TF PET/CT 882442

    Recall: Z-2276-2018 · Initiated March 28, 2018

    Recall

    Recall Number
    Z-2276-2018
    Event Number
    80176
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2018
    Terminated
    April 21, 2020
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Ingenuity TF PET/CT 882442

    Reason

    A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

    Action

    Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.

    Distribution

    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.

    Quantity

    28 total