FDA-Device2018-04-11Class II
Dynavox T15 Speech Generating Device ( including Batteries)
Dynavox Systems Llc
Hazard
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.
Sold states
Nationally
Affected count
307
Manufactured in
2100 Wharton St Ste Ste 400, N/A, Pittsburgh, PA, United States
Products
Dynavox T15 Speech Generating Device ( including Batteries)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2018Don't want to check this manually?
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