BEUDAMED
    FDA Enforcement Class II Ongoing

    PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application

    Recall: Z-2005-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2005-2023
    Event ID
    92250
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Permobil
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 5, 2023
    Initiation Date
    May 10, 2023
    Classification Date
    June 26, 2023
    Address
    300 Duke Dr, N/A, Lebanon, TN, 37090-8115, United States

    Description

    PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application

    Reason

    When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.

    Code Info

    All units with software versions 1.0.00 to 1.0.04

    Distribution

    Worldwide distribution.

    Quantity

    6,196 units