BEUDAMED
    FDA Recall Terminated

    LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA

    Recall: Z-0078-04 · Initiated October 3, 2003

    Recall

    Recall Number
    Z-0078-04
    Event Number
    27447
    Firm
    Electro Medical Systems (EMS SA) Rte de Champ-Colin
    FEI Number
    3004096429
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2003
    Posted
    October 31, 2003
    Terminated
    July 20, 2004
    Address
    2 Nyon Switzerland

    Description

    LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA

    Reason

    Failure of foot pedal to activate device

    Action

    EMS notified US Distributor Boston Scientific by letter dated 10/3/03 advising them to to determine the client base and provide replacement foot pedals to the final user. Boston Scientific/Microvasive notified Hospital Risk Managers by letter dated 10/6/03.Sales representatives will visit accounts to replace the foot pedal.

    Distribution

    Nationwide Government: VA Hospitals:Decatur, GA;Biloxi, MS; Omaha,NB, Oklahoma CIty, OK;Muskogee, OK, West Palm Beach, FL Walter Reed Army Medical Center, Washington, DC

    Quantity

    96 units