Z-1399-2023 Class II Ongoing
FDA device recall Z-1399-2023 was initiated by Tobii Dynavox Llc on February 24, 2023 and is designated Class II. Reason for recall: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. The recall status is ongoing. Affected quantity: 3924 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- February 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3924 units
Product Description
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 Pattern
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.
Code Information
UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400