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GEN4 DIGITAL
CURBELL MEDICAL PRODUCTS, INC. · Model 4D360N-Z104228 · UDI-DI 00840828113595
10
510(k) clearances
37
Adverse events (4 deaths)
17
Recalls
18
Facilities
Description
GEN4 DIGITAL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-08 | Securitas Healthcare LLC | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low batt |
| 2025-12-08 | Securitas Healthcare LLC | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low batt |
| 2024-11-01 | Securitas Healthcare LLC | Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System. |
| 2024-06-20 | Securitas Healthcare LLC | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery. |
| 2024-06-20 | Securitas Healthcare LLC | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery. |
| 2024-04-11 | Securitas Healthcare LLC | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events |
| 2023-09-25 | Securitas Healthcare LLC | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. |
| 2023-09-25 | Securitas Healthcare LLC | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. |
| 2023-09-25 | Securitas Healthcare LLC | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. |
| 2023-02-06 | Securitas Healthcare LLC | The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices. |
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