BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-1409-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1409-2022
    Event ID
    90532
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    February 19, 2021
    Classification Date
    July 19, 2022
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    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.

    Code Info

    UDI-DI: 04046955206742, Serial Number: SN1004

    Distribution

    United States: NE

    Quantity

    1