Recall Z-1304-2018 ยท ILQ System, Communication, Powered
Dynavox Systems Llc
Dynavox T10 Speech Generating Device ( including Batteries)
| Date | Dec 14, 2017 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.