BEUDAMED
    FDA Recall Terminated

    Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.

    Recall: Z-3092-2011 · Initiated February 6, 2009

    Recall

    Recall Number
    Z-3092-2011
    Event Number
    59754
    Firm
    Covidien, PLC
    FEI Number
    1717344
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 6, 2009
    Posted
    August 30, 2011
    Terminated
    August 30, 2011
    Address
    5920 Longbow Dr, Boulder, CO, 80301-3202

    Description

    Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.

    Reason

    Generator may deliver full power when a lower power is selected.

    Action

    Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK.

    Quantity

    357 units