BEUDAMED
    FDA Recall Terminated

    Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .

    Recall: Z-0684-2007 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0684-2007
    Event Number
    37168
    Firm
    E.M.S. Electro Medical Systems SA Chemin de la Vuarpilliere 31 Nyon, Vaud Switzerland
    FEI Number
    3002806910
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    March 30, 2007
    Terminated
    February 2, 2016

    Description

    Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .

    Reason

    Handpiece may become dislodged causing cable damage and possible electric shock.

    Action

    EMS Lyon, France (manufacturer) notified the single US Distributor by letter to contact their accounts and return device for replacement. Boston Scientific, Natick, Ma conducted the sub-recall by letter dated 4/22/05 to all USA accounts.

    Distribution

    Nationwide

    Quantity

    160 units