BEUDAMED
    FDA Recall Terminated

    GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. Intended to be used for general purpose radiography and tomography.

    Recall: Z-0457-2010 · Initiated July 30, 2009

    Recall

    Recall Number
    Z-0457-2010
    Event Number
    52720
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    IZZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2009
    Posted
    November 25, 2009
    Terminated
    May 19, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. Intended to be used for general purpose radiography and tomography.

    Reason

    GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.

    Action

    Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.

    Quantity

    1046