Z-2960-2026 Class II Ongoing
FDA device recall Z-2960-2026 was initiated by Tobii Dynavox Llc on July 8, 2026 and is designated Class II. 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 local… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).