BEUDAMED
    FDA Recall Terminated

    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

    Recall: Z-2197-2015 · Initiated July 1, 2015

    Recall

    Recall Number
    Z-2197-2015
    Event Number
    71699
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 1, 2015
    Posted
    July 22, 2015
    Terminated
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

    Reason

    Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

    Action

    On 7/6/2015 the firm sent Field Safety Notices to their customers.

    Distribution

    Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

    Quantity

    1 unit