FDA recall Z-1304-2018

Product

Dynavox T10 Speech Generating Device ( including Batteries)

Reason for recall

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.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-12-14

Report date

2018-04-11

Termination date

2019-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1304-2018