BEUDAMED
    FDA Recall Open, Classified

    Clinician Programmer Application (CPA) model A610 Clinician Software Application

    Recall: Z-0201-2022 · Initiated September 23, 2021

    Recall

    Recall Number
    Z-0201-2022
    Event Number
    88761
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 23, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Clinician Programmer Application (CPA) model A610 Clinician Software Application

    Reason

    A software anomaly may occur with the clinician programmer application.

    Action

    A customer letter was distributed to impacted customers beginning September 16, 2021. Customers are asked to contact their Medtronic representative or Medtronic Technical Services at 1-800-707-0933 to troubleshoot should they experience the software anomaly issue.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.

    Quantity

    3302