FDA Medical Device Recalls (openFDA)
Tobii Dynavox Llc: Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
- Recall number
- Z-1399-2023
- Recalling firm
- Tobii Dynavox Llc
- Product
- Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
- Status
- Open, Classified
- Initiated
- 2023-02-24
- Posted
- 2023-04-18
- Terminated
- not on file
- Reason
- Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
- Root cause
- Device Design
- 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: Recall@tobiidynavox.com 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.
- Quantity
- 3924 units
- 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.
- Lot, serial or model codes
- UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 3004959902
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28