BEUDAMED
    FDA Enforcement Class II Terminated

    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

    Recall: Z-1187-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1187-2019
    Event ID
    82451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus ACMI, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 8, 2019
    Classification Date
    April 17, 2019
    Termination Date
    May 8, 2020
    Address
    2925 Appling Rd, N/A, Bartlett, TN, 38133-3901, United States

    Description

    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

    Reason

    Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

    Code Info

    All lot numbers

    Distribution

    Nationwide Foreign: Germany,Japan, Singapore

    Quantity

    161