BEUDAMED
    FDA Recall Terminated

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    Recall: Z-2792-2018 · Initiated May 15, 2018

    Recall

    Recall Number
    Z-2792-2018
    Event Number
    80327
    Firm
    Megadyne Medical Products, Inc.
    FEI Number
    1721194
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    May 15, 2018
    Posted
    August 13, 2018
    Terminated
    January 30, 2024
    Address
    11506 S State St, Draper, UT, 84020-9453

    Description

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    Reason

    If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

    Action

    The firm sent letters in June 2018, informing their customers of the issue. The firm will send labels that can be applied to the product to remind them not to plug 2 active devices into the same channel at a time. Updated 08/13/19 Starting on 06/29/18, updated Medical Device Correction Notifications and labels were mailed via second day service. Customers were asked to complete and return Business Reply Forms.

    Distribution

    Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets

    Quantity

    8380 units