BEUDAMED
    FDA Enforcement Class II Terminated

    GEMINI GXL 16 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-2193-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2193-2015
    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 GXL 16 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 #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A.

    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

    2 units