Recall Z-2959-2026— Tobii Dynavox Llc
Class II · Ongoing
Class II FDA medical device recall by Tobii Dynavox Llc, initiated 2026-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798. Reason: 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..
- Recalling firm
- Tobii Dynavox Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-08
- Firm location
- Pittsburgh, PA, United States
Product description
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.