Official recall notice
FDA Recall: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- Recall date
- 2026-08-26
- Brand
- Tobii Dynavox Llc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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
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).