Dynavox Systems Llc: Medical Device Recall in 2018 - (Recall #: Z-1304-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Dynavox T10 Speech Generating Device ( including Batteries)

Product Classification:

Class II

Date Initiated: December 14, 2017

Date Posted: April 11, 2018

Recall Number: Z-1304-2018

Event ID: 79433

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.

Status: Terminated

Product Quantity: 4615

Code Information:

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.

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated