CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report

Dynavox T15 Speech Generating Device ( including Batteries) recalled

Dynavox Systems is recalling Dynavox T15 Speech Generating Device ( including Batteries), distributed nationwide in the US. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTL1405 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.

Quantity recalled307

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1305-2018
FDA event ID: 79433
Recalling firm: Dynavox Systems, Pittsburgh, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2017
FDA classified: 3 Apr 2018
Reported: 11 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Dec 2017	Recall initiated by company
3 Apr 2018	Classified by FDA	+110 days
11 Apr 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Dynavox T15 Speech Generating Device ( including Batteries)

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is Dynavox T15 Speech Generating Device ( including Batteries) recalled?

Yes. Dynavox Systems recalled Dynavox T15 Speech Generating Device ( including Batteries) on 14 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1305-2018.

Why was it recalled?

Which lots 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.

Where was it sold?

Nationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Dynavox Systems

All 2

Reported	Class	Recall	Company	Reason	Where
11 Apr 2018Device	CLASS II	Dynavox T10 Speech Generating Device ( including Batteries) recalled	Dynavox Systems	Device Malfunction	Nationwide

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