CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report
TD I-110 Speech Device-tablet style speech generating recalled
Tobii Dynavox is recalling Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for, distributed nationwide in the US. The recall was initiated on 24 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1399-2023
- FDA event ID
- 91884
- Recalling firm
- Tobii Dynavox, Pittsburgh, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Feb 2023
- FDA classified
- 18 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 24 Feb 2023 | Recall initiated by company | |
| 18 Apr 2023 | Classified by FDA | +53 days |
| 26 Apr 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Where it was distributed
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.
Questions about this recall
Is TD I-110 Speech Device-tablet style speech generating device used for ambulatory people recalled?
Yes. Tobii Dynavox recalled TD I-110 Speech Device-tablet style speech generating device used for ambulatory people on 24 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1399-2023.
Why was it recalled?
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Which lots are affected?
UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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