BEUDAMED
    FDA Recall Terminated

    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.

    Recall: Z-0023-2014 · Initiated March 26, 2013

    Recall

    Recall Number
    Z-0023-2014
    Event Number
    65958
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    March 26, 2013
    Posted
    October 17, 2013
    Terminated
    December 5, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.

    Reason

    GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID

    Action

    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.

    Quantity

    380 (52 US & 328 OUS)