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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Dynavox Systems Llc: 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.

Agency Publication Date: April 3, 2018
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Affected Products

Product: Dynavox T10 Speech Generating Device ( including Batteries)

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.

Product: Dynavox T15 Speech Generating Device ( including Batteries)

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.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79433
Status: Resolved
Manufacturer: Dynavox Systems Llc
Manufactured In: United States
Units Affected: 2 products (4615; 307)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.