# FDA recall Z-1305-2018

> **Dynavox Systems Llc** · Class II · device recall initiated 2017-12-14.

## Product

Dynavox T15 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

- **Recall number:** Z-1305-2018
- **Recalling firm:** Dynavox Systems Llc
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2018

## Citation

> AI Analytics. FDA recall Z-1305-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1305-2018. Source: US FDA. Licensed CC0.

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