Recall Z-2959-2026 ยท ILQ System, Communication, Powered
Tobii Dynavox Llc
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
| Date | Aug 14, 2026 (initiated Jul 8, 2026) |
| Status | Open, Classified |
| Reason | Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure. |
| Root cause | Device Design |
| Action | On July 8, 2026, the firm notified customers by emailing letters titled "URGENT: MEDICAL DEVICE RECALL NOTICE." Customers were informed that Tobii Dynavox would provide a repair authorization number (RA#), prepaid shipping label, inspection, repair, and return shipping for the affected device. The repair will include modifications intended to improve battery stability within the device. Customers were provided with ways to contact the company to obtain a repair authorization number. Customers were informed that it is safe to continue using the device as intended while waiting for the repair |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.