BEUDAMED
    FDA Enforcement Class II Terminated

    Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

    Recall: Z-1966-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1966-2020
    Event ID
    85393
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Magstim Company Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    March 23, 2020
    Classification Date
    May 13, 2020
    Termination Date
    September 20, 2024
    Address
    Spring Gardens, N/A, Whitland, N/A, N/A, United Kingdom

    Description

    Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

    Reason

    It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

    Code Info

    Product Code: 3853-00

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.

    Quantity

    71 units total