BEUDAMED
    FDA Recall Completed

    Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

    Recall: Z-1409-2022 · Initiated February 19, 2021

    Recall

    Recall Number
    Z-1409-2022
    Event Number
    90532
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    FSO
    Status
    Completed
    Root Cause
    Material/Component Contamination
    Initiated
    February 19, 2021
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

    Reason

    Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

    Action

    An Urgent Market Withdrawal Notification letter issued February 19, 2021 was mailed USPS certified. The letter identifies the Universal Robot UR5 arm as part of hte Aesculap Aeos System and requests the customer return the acknowledgement form and schedule repair by service technician.

    Distribution

    United States: NE

    Quantity

    1