BEUDAMED
    FDA Enforcement Class II Terminated

    INVUITY(R) PhotonBlade(TM), REF PB1

    Recall: Z-2778-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2778-2017
    Event ID
    77607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invuity, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 2, 2017
    Initiation Date
    June 12, 2017
    Classification Date
    July 27, 2017
    Termination Date
    June 28, 2023
    Address
    444 De Haro St, N/A, San Francisco, CA, 94107-2347, United States

    Description

    INVUITY(R) PhotonBlade(TM), REF PB1

    Reason

    A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.

    Code Info

    All Lot Numbers

    Distribution

    nationwide

    Quantity

    1328 units