Dynavox Systems Llc recalls Dynavox T10 Speech Generating Device ( including Batteries)

Recall date

December 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1304-2018

FDA classification

Class II

Brand / firm

Dynavox Systems Llc

Sold / distributed

Nationally

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dynavox T10 Speech Generating Device ( including Batteries)