BEUDAMED
    FDA Enforcement Class II Completed

    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

    Recall: Z-0037-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0037-2025
    Event ID
    95194
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    QUANTUM SURGICAL SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 16, 2024
    Initiation Date
    August 5, 2024
    Classification Date
    October 9, 2024
    Address
    1000 rue du mas de verchant, ZAC Eureka, montpellier, N/A, France

    Description

    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

    Reason

    Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

    Code Info

    UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017

    Distribution

    US Nationwide distribution in the state of FL.

    Quantity

    2 units