BEUDAMED
    FDA Enforcement Class II Terminated

    GEMINI TF 64 Slice 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-2196-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2196-2015
    Event ID
    71699
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    July 1, 2015
    Classification Date
    July 22, 2015
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    GEMINI TF 64 Slice 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.

    Code Info

    Model #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552.

    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

    22 Units