TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 recall (Tobii Dynavox Llc)
Medical deviceClass IIOngoing
Summary: Tobii Dynavox Llc is recalling TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799. Reason: 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.
What is being recalled
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
UDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2960-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 8, 2026 |
| Reported | August 26, 2026 |
| Company | Tobii Dynavox Llc |
| Company location | Pittsburgh, PA, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Tobii Dynavox Llc · all medical device recalls · recalls from July 2026