BEUDAMED
    FDA Recall Terminated

    GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.

    Recall: Z-1088-2007 · Initiated June 6, 2006

    Recall

    Recall Number
    Z-1088-2007
    Event Number
    44936
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2006
    Posted
    September 28, 2007
    Terminated
    December 8, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.

    Reason

    The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).

    Action

    Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.

    Distribution

    World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.

    Quantity

    161