FDA recall Z-2960-2026

Tobii Dynavox Llc · Class II · device

Product

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Reason for recall

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-07-08
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2960-2026