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Terminated

Dynavox T15 Speech Generating Device ( including Batteries)

FDA Recall Z-1305-2018 · Posted None

Recalling FirmDynavox Systems Llc
Recall StatusTerminated
Product CodeILQ
Date Initiated2017-12-14
Date Terminated2019-12-11
Product Quantity307

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.

Firm Action

On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.

Root Cause

Component design/selection

Distribution Pattern

Nationally

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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