DeviceSignal · Recall classified
Tobii Dynavox Llc
FDA classified a device recall on 2026-08-14 · Class II · Z-2959-2026
EventRecall classified
Effective2026-08-14
ClassificationClass II
On 2026-08-14 the FDA classified a device recall from Tobii Dynavox Llc as Class II. Product: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798. Recall Z-2959-2026. The firm initiated it on 2026-07-08. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2959-2026
- Classification
- Class II
- Classified on
- 2026-08-14
- Initiated on
- 2026-07-08
- Firm
- Tobii Dynavox Llc
- 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.
- Product
- TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2959-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
ab094eac70cb492f6d478d7a0389fd0c32aa3ed4f796102cf6bc6fc2fc6aa263- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)