FDA-Device2026-08-26Class IIPROCESSING DEFECT
Tobii Dynavox TD Navio Midi speech device recalled for battery short-circuit risk
What this means
The battery mounting tabs in some TD Navio Midi speech-generating devices may become damaged, allowing the battery to shift inside the device. This can cause an internal short circuit, leading to localized heating and gas venting inside the device enclosure.
- Check if your device serial number falls between TDNM1-240628000004 and TDNM1-260617070001.
- If affected, stop using the device and contact Tobii Dynavox for a replacement or repair.
- Do not attempt to repair or adjust the battery mounting yourself.
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Manufactured in
2100 Wharton St Ste Ste 400, Pittsburgh, PA, United States
Products
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2959-2026Want us to check the next one for you?
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