Recall Z-1399-2023 ยท ILQ System, Communication, Powered
Tobii Dynavox Llc
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
| Date | Apr 18, 2023 (initiated Feb 24, 2023) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.