BEUDAMED
    FDA Recall Terminated

    INVUITY(R) PhotonBlade(TM), REF PB1

    Recall: Z-2778-2017 · Initiated June 12, 2017

    Recall

    Recall Number
    Z-2778-2017
    Event Number
    77607
    Firm
    Invuity, Inc.
    FEI Number
    3007037347
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 12, 2017
    Terminated
    June 28, 2023
    Address
    444 De Haro St, San Francisco, CA, 94107-2347

    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.

    Action

    Official notices were sent to customers via FedEx overnight on 6/14/17. Email notices were sent to the sales personnel 06/12/2017 regarding the return of their trunk stock inventory and asking them to also contact customers who had been sent letters.

    Distribution

    nationwide

    Quantity

    1328 units