BEUDAMED
    FDA Recall Terminated

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    Recall: Z-1279-2015 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1279-2015
    Event Number
    70673
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 5, 2015
    Posted
    March 13, 2015
    Terminated
    August 17, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    Reason

    GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 40865 dated March 5, 2015. The letter was addressed to Managers of Nuclear Medecine, Hospital Administrators / Risk Managers and Managers of Radiology /Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact in the United States: 1-800-437-1171. For other countries, contact your local GE Healthcare Service Representative.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NY, NC, OK, PA, PR, SD, TN, TX, VA, WA, WV, WI. and the countries of URUGUAY, UNITED KINGDOM,UKRAINE, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVAKIA, RUSSIA,PORTUGAL, POLAND, PERU, NORWAY, NETHERLANDS, MEXICO, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, INDIA, GREECE, GERMANY, FRANCE, ESTONIA, DENMARK, CZECH REPUBLIC, CYPRUS, COLOMBIA, CHINA, CANDA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA.

    Quantity

    472 (127 units US, 345 units OUS)