BEUDAMED
    FDA Enforcement Class II Ongoing

    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

    Recall: Z-0423-2022 · Reported January 5, 2022

    Enforcement

    Recall Number
    Z-0423-2022
    Event ID
    89134
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Forbes Rehab Services Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 5, 2022
    Initiation Date
    October 11, 2021
    Classification Date
    December 28, 2021
    Address
    181 Illinois Ave S, Mansfield, OH, 44905-2825, United States

    Description

    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

    Reason

    Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

    Code Info

    All units

    Distribution

    US Nationwide distribution.

    Quantity

    3065 units