Tobii Dynavox Recalls TD Navio Midi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Midi 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 is classified as FDA Class II and involves a risk of internal short circuits leading to localized heating and gas venting, which aligns with the rubric criteria for significant injury or property damage reports.
Plain-English summary
Tobii Dynavox LLC is recalling the TD Navio Midi Speech Generating Device, Model/Catalog Number 1000798. The recall covers devices with UDI-DI 073400747602056 and serial numbers ranging from TDNM1-240628000004 through TDNM1-260617070001. These devices were distributed nationwide in the United States.
The recall is being issued because, under certain conditions, the battery mounting tabs may become damaged. This damage can allow 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 device.
Consumers should stop using the affected devices and contact Tobii Dynavox for further instructions. Corrected and future production units are differentiated by new serialization starting from TDNM1-260617070001 onward, which includes an improved design.
The recalled product
- Product
- TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- 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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