Home › CURBELL MEDICAL PRODUCTS, INC. › GEN4 Direct Access
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC. · Model 4C110N-Z103218 · UDI-DI 00840828102407
10
510(k) clearances
714
Adverse events (22 deaths)
19
Recalls
45
Facilities
Description
GEN4 Direct Access
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.