BEUDAMED
    FDA Enforcement Class II Terminated

    Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:

    Recall: Z-1259-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1259-2019
    Event ID
    82582
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    March 20, 2019
    Classification Date
    May 2, 2019
    Termination Date
    October 5, 2020
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:

    Reason

    During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

    Code Info

    Mfg. Lot or Serial # System ID Model, Catalogue or Code # DRGX56002 SHIPPED (GON 4683652) H3100BT DDRX34058 909558D670NM H3100AN DDRX34056 650723D670 H3100AN DDRX34053 SHIPPED (AO 1614951) H3100AN DRGX56005 614CVA6702 H3100BT DRGX56017 110002NU06 H3100BT DRGX56004 403343D670A H3100BT DRGX56018 X7410502 H3100BT DRGX56009 083026206531618 H3100BT DRGX56012 STD01300 H3100BT DDRX34055 00362NUC04 H3100AN

    Distribution

    US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

    Quantity

    11 units