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Dynavox Systems Llc recalls Dynavox T10 Speech Generating Device ( including Batteries)
Recalled April 11, 2018 · FDA recall Z-1304-2018 · Dynavox Systems
Hazard
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount. · FDA Class II
Units
4615
Sold at
Nationally
Description
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
Product
Dynavox T10 Speech Generating Device ( including Batteries)
Manufacturer(s)
Dynavox Systems Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →