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TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

Class II
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.
Affected products (lot / model / serial)
UDI-DI 073400747602056 Serial Numbers TDNM1-240628000004 through TDNM1-260617070001. Corrected/future production is differentiated by new serialization from TDNM1-260617070001 onward (production batch 20260615, improved design).
Distribution pattern
US Nationwide distribution.
Firm location
Pittsburgh, PA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2959-2026
Recall initiated
July 8, 2026
FDA classification date
August 14, 2026
FDA report date
August 26, 2026
FDA event ID
99410
Last updated on HTM Vibe
September 8, 2026
View on openFDA