BEUDAMED
    FDA Enforcement Class II Terminated

    Dynavox T10 Speech Generating Device ( including Batteries)

    Recall: Z-1304-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1304-2018
    Event ID
    79433
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dynavox Systems Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    December 14, 2017
    Classification Date
    April 3, 2018
    Termination Date
    December 11, 2019
    Address
    2100 Wharton St Ste Ste 400, N/A, Pittsburgh, PA, 15203-1691, United States

    Description

    Dynavox T10 Speech Generating Device ( including Batteries)

    Reason

    The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.

    Code Info

    TS1308 TS1411 Part Numbers: T10: 750394 Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.

    Distribution

    Nationally

    Quantity

    4615