Dynavox T15 Speech Generating Device ( including Batteries)
FDA Recall #Z-1305-2018 — Class II — December 14, 2017
Product Description
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.
Recalling Firm
Dynavox Systems Llc — Pittsburgh, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
307
Distribution
Nationally
Code Information
TL1405 TL1407 Part Numbers: T15: 750423 Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated