FDA recall Z-1399-2023

Product

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

Reason for recall

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

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.

Key facts

Status

Ongoing

Initiation date

2023-02-24

Report date

2023-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2023