FDA Medical Device Recalls (openFDA)
Dynavox Systems Llc: Dynavox T10 Speech Generating Device ( including Batteries)
- Recall number
- Z-1304-2018
- Recalling firm
- Dynavox Systems Llc
- Product
- Dynavox T10 Speech Generating Device ( including Batteries)
- Status
- Terminated
- Initiated
- 2017-12-14
- Posted
- not on file
- Terminated
- 2019-12-11
- 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.
- Root cause
- Component design/selection
- 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.
- Quantity
- 4615
- Distribution
- Nationally
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 3004959902
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28