BEUDAMED
    FDA Recall Terminated

    Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.

    Recall: Z-0933-2008 · Initiated December 28, 2007

    Recall

    Recall Number
    Z-0933-2008
    Event Number
    46293
    Firm
    Sound Surgical Technologies, LLC
    FEI Number
    3004106598
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 28, 2007
    Posted
    March 13, 2008
    Terminated
    April 1, 2008
    Address
    357 Mccaslin Blvd, Ste 100, Louisville, CO, 80027-2951

    Description

    Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.

    Reason

    Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

    Action

    Consignees were sent an Advisory Notice on 12/28/2007. The notification describes the defect. Sound Surgical will be contacting facilities to arrange a service call to install new cables between the footswitch receiver and the VASER system. Facilities may contact the Technical Service Center at 1-888-677-8765.

    Distribution

    Worldwide Distribution including USA states of AL, CA, CT, FL, GA, IN, KY, LA, MI, NJ, NY, OH, OK, PA, TX, and VA. Foreign Distribution to Colombia, Costa Rica and Switzerland.

    Quantity

    127 switches