BEUDAMED
    FDA Enforcement Class II Terminated

    NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.

    Recall: Z-1263-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1263-2019
    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

    NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.

    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 # 860Y62005 SHIPPED (GON 4736850) H3908AD 850X61003 401793860NM H3908AD 860X62001 E6843969 H3908AE 870X64005 HC4387NU05 H3100AS 860Y62004 083026212959219 H3908AD 860X62002 PL0399NM01 H3908AD

    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

    6 units