Dynavox T15 Speech Generating Device Recalled Due to Battery Defect
Dynavox Systems LLC is recalling 307 T15 Speech Generating Devices because the integral battery may out-gas and swell after long periods of disuse, potentially causing 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (battery out-gassing and case separation) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Dynavox Systems LLC is recalling 307 units of the Dynavox T15 Speech Generating Device, including the integral batteries. The recall was initiated because the battery may enter a deep discharge state and expire if the device sits unused and uncharged for a lengthy period, such as a few months.
When the battery expires, it may out-gas, which can be described as swelling or puffing as gas becomes trapped inside the pack surrounding the cells. This out-gassing may cause the device case to separate a small amount. The affected units were distributed nationally and are identified by part number T15: 750423, with date codes included in the device's unique serial number representing the year and month of manufacture.
Consumers should stop using the affected devices and contact Dynavox Systems LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Dynavox T15 Speech Generating Device ( including Batteries)
- Manufacturer
- Dynavox Systems Llc
- Affected units
- 307
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
See all →- ModerateDynavox T10 Speech Generating Device Recalled for Battery Swelling
FDA (Devices) · 2018-04-11
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