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

Recall date

February 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1399-2023

FDA classification

Class II

Brand / firm

Tobii Dynavox Llc

Sold / 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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567