Z-2960-2026Class II

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

Name: Z-2960-2026 TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Creator: Tobii Dynavox Llc
Published: 2026-07-08
License: https://open.fda.gov/license/

Tobii Dynavox LLC / initiated 2026-07-08 / Open, Classified / root cause: design

FDA source

Tobii Dynavox Llc began a recall of TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 on 2026-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2960-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-08
Posted: 2026-08-14
Recalling firm: Tobii Dynavox LLC
Product: TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Product code: ILQ System, Communication, Powered
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Distribution: US Nationwide distribution.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2960-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2959-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2960-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)