BEUDAMED
    FDA Enforcement Class II Ongoing

    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)

    Recall: Z-0836-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0836-2019
    Event ID
    81489
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The Magstim Company Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2019
    Initiation Date
    October 25, 2018
    Classification Date
    February 14, 2019
    Address
    Spring Gardens, N/A, Whitland, N/A, N/A, United Kingdom

    Description

    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)

    Reason

    A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.

    Code Info

    Product #: 5162-00 Serial #'s: 55308/001, 55308/002, 55310/001, 55310/002, 55446/001, 55446/002, 55447/001, 55447-002, 55631-001, 55631-002, 55631-003, 55631-004, 55632/001, 55632/002, 55632/003, 55632/004, 55841/001, 55841-002, 55841-003, 55841-004, 55842/001, 55842/002, 55842/003, 55842/004, 55843-001, PLT00015/001 and PLT00015/002

    Distribution

    CA, MA, MN, PA, TX, VA, WI, and WA

    Quantity

    27 (including 2 demos)