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Dynavox T10 Speech Generating Device ( including Batteries)

FDA Recall #Z-1304-2018 — Class II — December 14, 2017

Recall #Z-1304-2018 Date: December 14, 2017 Classification: Class II Status: Terminated

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.

Recalling Firm

Dynavox Systems Llc — Pittsburgh, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4615

Distribution

Nationally

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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