BEUDAMED
    FDA Recall Terminated

    Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System

    Recall: Z-0105-06 · Initiated September 27, 2005

    Recall

    Recall Number
    Z-0105-06
    Event Number
    33832
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2005
    Posted
    October 28, 2005
    Terminated
    December 26, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System

    Reason

    Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured.

    Action

    GE Healthcare issued an Urgent Safety Notice, dated 07/22/05, to all affected sites. This letter describes the potential hazard, its waring signs and the additional corrective actions that will be taken by GE Healthcare.

    Distribution

    Within the US to include: AL, AZ, CA, DE, FL, GA, IA, IL, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, VA, WI and WV. OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Greece, Italy, Korea, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sinapore, Spain, Sweden and United Kingdom

    Quantity

    140 (80 US and 60 OUS)