Tobii Dynavox Llc: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Tobii Dynavox Llc
- Product
- TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-07-08
- Code info
- 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).
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Pittsburgh
- State
- PA
- Country
- United States
- Event id
- 99410
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