Tobii Dynavox Recalls TD Navio Maxi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Maxi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a risk of internal short circuit leading to localized heating and gas venting, which constitutes a significant injury risk (burns/fire) for a medical device, aligning with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Tobii Dynavox Llc is recalling TD Navio Maxi Speech Generating Devices, Model/Catalog Number 1000799. The recall covers devices with UDI-DI 073400747602070 and serial numbers ranging from TDNL1-240904000016 through TDNL1-260617070001. These devices were distributed nationwide in the United States.
The recall is due to a defect where battery mounting tabs may become damaged under certain conditions. This damage allows the battery to move within the device enclosure, potentially leading to an internal short circuit. Such a short circuit may cause localized heating and gas venting within the enclosure.
Consumers should stop using the affected devices and contact Tobii Dynavox for instructions on how to proceed. Corrected production units are differentiated by new serialization starting from TDNL1-260617070001 onward, associated with production batch 20260615 and an improved design.
The recalled product
- Product
- TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
- Manufacturer
- Tobii Dynavox Llc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- improved design).
Distribution
Distributed nationwide across the United States.
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