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Recall Observatory FDA recall evidence

Device product

Dynavox T10 Speech Generating Device ( including Batteries)

Z-1304-2018

December 14, 2017

Class II

Product summary

Firm
Dynavox Systems Llc
Event
Event 79433
Status
Terminated
Classification
Class II
Quantity
4615
Official record key
device-enforcement:Z-1304-2018

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.