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Tobii Dynavox TD I-110 Speech Device-tablet style speech… recallZ-1399-2023 · Tobii Dynavox Llc · initiated Feb 24, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tobii Dynavox Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1399-2023
Status
Open, Classified
Initiated by the company
Feb 24, 2023
Posted by the FDA
Apr 18, 2023
Recalling firm
Tobii Dynavox Llc
Quantity
3924 units
Product code
ILQ
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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