BEUDAMED
    FDA Recall Terminated

    Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)

    Recall: Z-0854-06 · Initiated October 8, 2004

    Recall

    Recall Number
    Z-0854-06
    Event Number
    34516
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2004
    Posted
    May 9, 2006
    Terminated
    December 31, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)

    Reason

    Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with this version of software may introduce a shift of up to 1.5 PET Voxels, which can be as much as 8 mm with certain zoom factors.

    Action

    An Urgent Safety Notice letter, dated October 8, 2004,(5121309-147, rev.E) was distributed to affected customers and a validated software patch that corrected the problem was installed on affected systems via Field Modification Instruction (FMI) 80114.

    Distribution

    Distributed in 32 states: AK, AL, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV; Australia, Belgium, Brazil, Canada, Switzerland, Chile, Nigeria, China, France, Egypt, Ireland, Israel, Japan, Korea, the Netherlands, Norway, New Zealand, Phillipines, Sweden, and Taiwan.

    Quantity

    199