BEUDAMED
    FDA Recall Terminated

    Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.

    Recall: Z-2042-2008 · Initiated January 14, 2008

    Recall

    Recall Number
    Z-2042-2008
    Event Number
    46796
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 14, 2008
    Posted
    September 16, 2008
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.

    Reason

    Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system

    Action

    Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.

    Distribution

    USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV. OUSA: Hungary Algeria Argentina Australia Austria Belarus Belgium Bosnia Brazil Bulgaria Canada Chile China Columbia Czech Republic Denmark Egypt Finland France Georgia Germany Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Kuwait Latvia Lebanon Malaysia Malta Mexico Morocco Netherlands New Zealand Nigeria Norway Pakistan Panama Poland Portugal Puerto Rico Romania Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom Uruguay Venezuela Yugoslavia

    Quantity

    388