BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1905-2025 · Initiated April 23, 2025

    Recall

    Recall Number
    Z-1905-2025
    Event Number
    96831
    Firm
    VIRTUAL INCISION CORPORATION
    FEI Number
    3030285773
    Product Code
    SAB
    Status
    Completed
    Root Cause
    Software design
    Initiated
    April 23, 2025
    Posted
    June 4, 2025
    Address
    1501 Old Cheney Rd, Lincoln, NE, 68512-2505

    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.

    Action

    A "MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 4/22/25 was sent to customers. Actions to be taken by the Customer/User: Do not use the device and transition scheduled procedures to another minimally invasive surgical technique i.e. laparoscopic or other robotic assisted device. Remove the device from service using your internal institutional procedures (e.g. Lock-Out, Tag-Out) for device maintenance until Virtual Incision technicians service the devices on hand. There is no anticipated impact to the conduct of the clinical study under the IDE. Please complete the attached Acknowledgement and Receipt form and return to Virtual Incision to indicate you received this letter. Customer Service, Clinical Support Staff, [email protected],913-608-3214. Quality Assurance, Sr Director of Quality and Manufacturing Engineering, [email protected], 308-529-1987. Regulatory Affair, VP of Clinical and Regulatory Affairs, [email protected], 352-275-726. Type of Action by the Company: Virtual Incision will be working with your site representatives to schedule on-site servicing of the device with updated software for the Surgeon Control Console within 30 days from receipt of this letter. Immediate corrections have been implemented through the analysis of the system data. Results indicate that implemented software updates have resolved the issue that could contribute to this deficiency in the future. If you have any question, call 513-500-4459 or email: [email protected].

    Distribution

    US Distribution to States: CA, FL, NE

    Quantity

    3 units