BEUDAMED
    FDA Recall Terminated

    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188

    Recall: Z-0265-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-0265-2008
    Event Number
    45514
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 10, 2007
    Posted
    November 28, 2007
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188

    Reason

    Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should NOT BE USED.

    Action

    An Urgent Safety Notice to customers dated 9/10/07, was issued by the recalling firm informing them of the device defect, safety issues, warnings on future uses and promised new software updates to be installed by GE representatives, free of charge, beginning Nov. 2007.

    Distribution

    Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, CU, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Guam, and countries of Canada, Mexico. Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Australia, China, Honk Kong, Indonesia, Japan, Korea, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Albania, Austria, Azerbaijan, Bosnia, Belgium, Belarus, Switzerland, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Guadeloupe, Greece, Hungary , Ireland, Israel, Italy, Kuwait, Lebanon, Morocco, Netherlands, Norway, French Polynesia, Poland, Portugal, Russian Federation, Saudi Arabia, Sweden, Slovenia, Tunisia, Turkey, and South Africa.

    Quantity

    2,518