BEUDAMED
    FDA Recall Terminated

    Leica ARveo and M530 OH6 microscope systems.

    Recall: Z-2399-2020 · Initiated May 20, 2020

    Recall

    Recall Number
    Z-2399-2020
    Event Number
    85722
    Firm
    Leica Microsystems, Inc.
    FEI Number
    1423337
    Product Code
    EPT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 20, 2020
    Terminated
    May 13, 2021
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica ARveo and M530 OH6 microscope systems.

    Reason

    Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.

    Action

    The firm sent letters to consignees on May 20, 2020 advising them that they can continue to use the system pending this field update. Based on our data analysis, the probability of occurrence for this issue (excessive voltage fluctuation and a subsequent microscope shut off) is remote. However, please ensure that a functional check is performed prior to each surgery as described in section 16.1, directions for the operator of the instrument of the user manual.

    Distribution

    Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan

    Quantity

    Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.