FDAClass IIApril 11, 2018

Dynavox T15 Speech Generating Device recall

Dynavox T15 Speech Generating Device ( including Batteries)

Why was Dynavox T15 Speech Generating Device recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Dynavox T15 Speech Generating Device ( including Batteries)
Recalling firm
Dynavox Systems Llc
Quantity
307
Distribution
Nationally
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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