Recall archive / FDA device enforcement
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabiliti... — FDA record Z-1399-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Tobii Dynavox Llc
- Quantity
- 3924 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1399-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 26, 2023
- Recall initiation date
- Feb 24, 2023
- Center classification date
- Apr 18, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.