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

FDA device recall Z-2960-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

Tobii Dynavox Llc

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.

Action taken

On July 8, 2026, the firm notified customers by emailing letters titled "URGENT: MEDICAL DEVICE RECALL NOTICE." Customers were informed that Tobii Dynavox would provide a repair authorization number (RA#), prepaid shipping label, inspection, repair, and return shipping for the affected device. The repair will include modifications intended to improve battery stability within the device. Customers were provided with ways to contact the company to obtain a repair authorization number. Customers were informed that it is safe to continue using the device as intended while waiting for the repair, as long as there are no signs of overheating, swelling, unusual odor, smoke, deformation, or battery abnormality. If any of these conditions are observed, discontinue use immediately and contact Tobbi Dynavox.

Root cause

Device Design

Status

Open, Classified

Product code

ILQ

Distribution

US Nationwide distribution.

Date initiated

2026-07-08

Date posted

2026-08-14

Location

Pittsburgh, PA