Dynavox T10 Speech Generating Device Recalled for Battery Swelling
Dynavox Systems LLC is recalling 4,615 T10 Speech Generating Devices because the internal battery may swell and cause the device case to separate.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a physical defect (battery swelling and case separation) without reporting any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Dynavox Systems LLC is recalling 4,615 Dynavox T10 Speech Generating Devices, including their batteries, which were distributed nationally. The recall covers devices with specific part numbers and date codes that are part of the device's unique serial number.
The recall is due to a defect in the integral battery. If the device sits unused and is not charged for a lengthy period, the battery may enter a deep discharge state and expire. This can cause the battery to out-gas, resulting in a swollen or puffed appearance as gas becomes trapped inside the pack. The swelling may cause the device case to separate a small amount.
Consumers who have this product should stop using it and contact Dynavox Systems LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- Dynavox T10 Speech Generating Device ( including Batteries)
- Manufacturer
- Dynavox Systems Llc
- Affected units
- 4,615
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Dynavox Systems Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Dynavox Systems Llc
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FDA (Devices) · 2018-04-11
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