BEUDAMED
    FDA Enforcement Class II Ongoing

    Clinician Programmer Application (CPA) model A610 Clinician Software Application

    Recall: Z-0201-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0201-2022
    Event ID
    88761
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    September 23, 2021
    Classification Date
    November 4, 2021
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Clinician Programmer Application (CPA) model A610 Clinician Software Application

    Reason

    A software anomaly may occur with the clinician programmer application.

    Code Info

    Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081

    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