BEUDAMED
    FDA Enforcement Class II Ongoing

    Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

    Recall: Z-1748-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1748-2019
    Event ID
    82982
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 26, 2019
    Initiation Date
    February 12, 2019
    Classification Date
    June 19, 2019
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

    Reason

    GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

    Code Info

    Discovery IQ

    Distribution

    Nationwide Distribution

    Quantity

    1113 in total