BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System

    Recall: Z-1522-2008 · Initiated May 19, 2008

    Recall

    Recall Number
    Z-1522-2008
    Event Number
    49538
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 19, 2008
    Posted
    September 30, 2008
    Terminated
    June 30, 2016
    Address
    Po Box 7550, Madison, WI, 53707

    Description

    GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System

    Reason

    GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).

    Action

    An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.

    Distribution

    Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.

    Quantity

    87