BEUDAMED
    FDA Recall Terminated

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    Recall: Z-0979-2014 · Initiated December 5, 2013

    Recall

    Recall Number
    Z-0979-2014
    Event Number
    67305
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 5, 2013
    Posted
    February 12, 2014
    Terminated
    August 25, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    Reason

    The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.

    Action

    ON 12/5/2013 the firm sent Medical Device Correction Letters to their customers.

    Distribution

    Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.

    Quantity

    47 Units