TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Summary
The FDA issued a Class II for TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 by Tobii Dynavox Llc. Reason: Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading .
Details
Source
Device Recall
External ID
Z-2960-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Lot/Code Info: 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).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-08
Company
Pittsburgh, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Tobii Dynavox Llc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tobii Dynavox Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tobii Dynavox Llc have FDA actions?
Tobii Dynavox Llc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2960-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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