BEUDAMED
    FDA Enforcement Class II Terminated

    Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.

    Recall: Z-0287-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0287-2021
    Event ID
    86539
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 22, 2020
    Classification Date
    October 23, 2020
    Termination Date
    September 22, 2021
    Address
    300 Boston Scientific Way, N/A, Marlborough, MA, 01752-1291, United States

    Description

    Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.

    Reason

    Incorrectly installed base.

    Code Info

    Serial Number: VM031

    Distribution

    US Nationwide distribution including in the state of Rochester, MN.

    Quantity

    1 unit