Z-1304-2018Class II

Dynavox T10 Speech Generating Device ( including Batteries)

Name: Z-1304-2018 Dynavox T10 Speech Generating Device ( including Batteries)
Creator: Dynavox Systems Llc
Published: 2017-12-14
License: https://open.fda.gov/license/

Tobii Dynavox LLC / initiated 2017-12-14 / Terminated / root cause: design

FDA source

Dynavox Systems Llc began a recall of Dynavox T10 Speech Generating Device ( including Batteries) on 2017-12-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1304-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-04-03
Terminated: 2019-12-11
Recalling firm: Tobii Dynavox LLC
Product: Dynavox T10 Speech Generating Device ( including Batteries)
Product code: ILQ System, Communication, Powered
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.
Root cause tag: design
FDA 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 in commerce: 4615
Distribution: Nationally
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03
Z-1305-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)