BEUDAMED
    FDA Recall Terminated

    Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027

    Recall: Z-0939-2011 · Initiated December 21, 2010

    Recall

    Recall Number
    Z-0939-2011
    Event Number
    57630
    Firm
    Sound Surgical Technologies, LLC
    FEI Number
    3004106598
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 21, 2010
    Posted
    January 25, 2011
    Terminated
    February 8, 2011
    Address
    357 Mccaslin Blvd, Ste 100, Louisville, CO, 80027-2951

    Description

    Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027

    Reason

    Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.

    Action

    Customers were notified by e-mail with an Advisory Notice on 12/21/2010. The Notice identified the affected product and described the issue. The Notice also explained what the potential hazard involved along with a mechanism to eliminate the potential hazard. Sound Surgical would arrange a service call to implement the correction at the firm's expense. If customers experience this potential failure, they are to contact Sound Surgical Technologies at 1-888-677-8765 or 1-888-471-4777.

    Distribution

    Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .

    Quantity

    27 units