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Tobii Dynavox
TOBII DYNAVOX LLC · Model SC Tablet Mini · UDI-DI 07340074601929
10
510(k) clearances
714
Adverse events (22 deaths)
19
Recalls
45
Facilities
Description
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-08 | Tobii Dynavox Llc | 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. |
| 2026-07-08 | Tobii Dynavox Llc | 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. |
| 2023-02-24 | Tobii Dynavox Llc | Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. |
| 2022-05-31 | Baxter Healthcare Corporation | An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software version |
| 2022-04-13 | Baxter Healthcare Corporation | Firm discovered a firmware memory leak with a supplier-manufactured component. |
| 2022-04-13 | Baxter Healthcare Corporation | Firm discovered a firmware memory leak with a supplier-manufactured component. |
| 2022-03-28 | Medminder Systems, Inc. | Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feat |
| 2021-10-14 | Hill-Rom Inc. | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. |
| 2021-10-11 | Forbes Rehab Services Inc | Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other proper |
| 2017-12-14 | Dynavox Systems Llc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.