BEUDAMED
    FDA Recall Terminated

    Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation

    Recall: Z-1507-06 · Initiated September 5, 2006

    Recall

    Recall Number
    Z-1507-06
    Event Number
    36253
    Firm
    Conmed Electrosurgery
    FEI Number
    3004491689
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2006
    Posted
    September 19, 2006
    Terminated
    October 26, 2006
    Address
    7211 South Eagle Street, Centennial, CO, 80112

    Description

    Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation

    Reason

    Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

    Action

    Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.

    Distribution

    Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.

    Quantity

    19 units (International)