BEUDAMED
    FDA Recall Terminated

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    Recall: Z-3251-2018 · Initiated June 1, 2018

    Recall

    Recall Number
    Z-3251-2018
    Event Number
    80308
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 1, 2018
    Terminated
    February 2, 2022
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    Reason

    Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

    Action

    On 06/01/2018, Urgent Medical Device Correction letters and Consignee Response Forms were mailed to customers via overnight mail service. Customers were provided with additional information intended to supplement the system manual and instructed to call the firm at 1-888-826-5603 if they had any questions.

    Distribution

    U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel

    Quantity

    161