BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1399-2023 · Initiated February 24, 2023

    Recall

    Recall Number
    Z-1399-2023
    Event Number
    91884
    Firm
    Tobii Dynavox Llc
    FEI Number
    3004959902
    Product Code
    ILQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 24, 2023
    Posted
    April 18, 2023
    Address
    2100 Wharton St, Ste Ste 400, Pittsburgh, PA, 15203-1691

    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.

    Action

    Tobii Dynavox issued Urgent Medical Device Recall Letter on 2/24/23. Letter states reason for recall, health risk and action to take: Tobii Dynavox will, at its full expense, provide you with a repair authorization number (RA#) and a shipping label to have the device inspected and repaired by adding more stability to the battery s position within the device. What should you do? There are numerous ways to contact the company to obtain a RA#: Online: https://us.tobiidynavox.com/pages/recall Toll Free: 800-344-1778, press 1, then press 2 (for the TD I-110 team) By Email: [email protected] We will provide you with your RA# and shipping labels via email, or by phone and mail where email is not possible. We will expedite all recalled battery repairs and return shipping to you, so you are without your device for as short a time as possible. You should obtain a RA# for the free repair to ensure that your device continues working as expected. You can continue to use your device and charge it as usual until you receive your RA# and shipping label. As with any Lithium-Ion battery, you should never puncture or vent a battery pack. You should not attempt to change the battery yourself or to remove the battery. This should only be done by a trained service technician. The device should not be stored in extremely hot conditions, as stated in the product manual, over 158F or 70C. Please use any of the methods above to tell us if your device is no longer in service. We will continue to contact all customers regarding this recall to be sure all customers are notified.

    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