Pittsburgh, PA, United States
Dynavox Systems Llc recalls
1 recall recorded since 2018, most recently on 14 December 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 December 2017
- Terminated
- 11 December 2019
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1304-2018, Z-1305-2018
- Dynavox T10 Speech Generating Device ( including Batteries)
- Dynavox T15 Speech Generating Device ( including Batteries)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.