Recall Z-1304-2018— Dynavox Systems Llc
Class II · Terminated
Class II FDA medical device recall by Dynavox Systems Llc, initiated 2017-12-14, terminated 2019-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Dynavox T10 Speech Generating Device ( including Batteries). 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..
- Recalling firm
- Dynavox Systems Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-14
- Terminated
- 2019-12-11
- Firm location
- Pittsburgh, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.