Tobii Dynavox Llc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
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).
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →