FDA Device recall Z-1304-2018
Dynavox T10 Speech Generating Device ( including Batteries)
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of Dynavox T10 Speech Generating Device ( including Batteries) by Dynavox Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1304-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-14 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Dynavox Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | TS1308 TS1411 Part Numbers: T10: 750394 Date Codes are part of the device s unique Serial Number and represent…TS1308 TS1411 Part Numbers: T10: 750394 Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2018%22
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