BEUDAMED
    FDA Recall Terminated

    GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    Recall: Z-0692-2008 · Initiated November 15, 2007

    Recall

    Recall Number
    Z-0692-2008
    Event Number
    45845
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 15, 2007
    Posted
    January 31, 2008
    Terminated
    January 29, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    Reason

    Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the

    Action

    Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.

    Distribution

    Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.

    Quantity

    171