BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 10, 2023

    Recall

    Recall Number
    Z-2005-2023
    Event Number
    92250
    Firm
    Permobil
    FEI Number
    3008370857
    Product Code
    ITI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 10, 2023
    Posted
    June 26, 2023
    Address
    300 Duke Dr, Lebanon, TN, 37090-8115

    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.

    Action

    Permobil began notifying customers via in-person and through letters on 05/10/2023. Customers were instructed to examine their device and update their software to SmartDrive MX2+ Version 1.1.00, to acknowledge the update was conducted and the notification letter was understood through the field action portal, notify customers if the affected devices were further distributed. They were also instructed to discontinue using the affected device while waiting for the correction.

    Distribution

    Worldwide distribution.

    Quantity

    6,196 units