Z-1399-2023Class II

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with...

Name: Z-1399-2023 Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with...
Creator: Tobii Dynavox Llc
Published: 2023-02-24
License: https://open.fda.gov/license/

Tobii Dynavox LLC / initiated 2023-02-24 / Open, Classified / root cause: design

FDA source

Tobii Dynavox Llc began a recall of Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567 on 2023-02-24. FDA classified it as Class II and gives the reason as "Problem maintaining the stable placement of the battery may come loose from the housing and become damaged". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1399-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-24
Posted: 2023-04-18
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
Product code: ILQ System, Communication, Powered
Reason for recall: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Root cause tag: design
FDA 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: [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.
Quantity in commerce: 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.
Product codes and lots: UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1399-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1399-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-18

Product code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)