Reported Apr 11, 2018 · Terminated

Dynavox T15 Speech Generating Device ( including Batteries)

Dynavox Systems LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dynavox Systems Llc · 2100 Wharton St Ste Ste 400 · Pittsburgh, PA · 15203-1691

Is this the product you have?

  • Dynavox T15 Speech Generating Device ( including Batteries)
Lot codes and dates
  • TL1405 TL1407 Part NumbersT15: 750423 Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured
Amount recalled
307

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 11, 2019 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.