BEUDAMED
    FDA Enforcement Class II Completed

    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

    Recall: Z-1905-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1905-2025
    Event ID
    96831
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    VIRTUAL INCISION CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    April 23, 2025
    Classification Date
    June 4, 2025
    Address
    1501 Old Cheney Rd, N/A, Lincoln, NE, 68512-2505, United States

    Description

    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

    Reason

    The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.

    Code Info

    UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

    Distribution

    US Distribution to States: CA, FL, NE

    Quantity

    3 units