BEUDAMED
    FDA Enforcement Class II Ongoing

    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

    Recall: Z-1399-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1399-2023
    Event ID
    91884
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tobii Dynavox Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 26, 2023
    Initiation Date
    February 24, 2023
    Classification Date
    April 18, 2023
    Address
    2100 Wharton St Ste Ste 400, N/A, Pittsburgh, PA, 15203-1691, United States

    Description

    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

    Reason

    Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

    Code Info

    UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, United Arab Emirates, United Kingdom.

    Quantity

    3924 units