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

FDA device recall Z-1399-2023 · posted 2023-04-18 · Open, Classified

Recall details

Recalling firm

Tobii Dynavox Llc

Reason for recall

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

ILQ

Quantity affected

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, Netherla

Date initiated

2023-02-24

Date posted

2023-04-18

Location

Pittsburgh, PA