BEUDAMED
    FDA Recall Terminated

    GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.

    Recall: Z-0947-2013 · Initiated January 21, 2013

    Recall

    Recall Number
    Z-0947-2013
    Event Number
    64178
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 21, 2013
    Posted
    March 13, 2013
    Terminated
    January 16, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.

    Reason

    A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

    Action

    GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters dated January 18, 2013 and February 11, 2013 to all affected customers. The letters were addressed to Hospital Administrators / Risk Managers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The second letter dated February 11, 2013 was sent out to consignees which incorporated an additional model number (2270677-2) which was initially missed. Contact the firm 800-437-1171 for questions regarding these letters.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.

    Quantity

    297