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Amplion Care Assurance
AMPLION CLINICAL COMMUNICATIONS, INC. · Model F-CAS-63d6c96-1 · UDI-DI 00850016398475
10
510(k) clearances
38
Adverse events (4 deaths)
17
Recalls
18
Facilities
Description
Bootloader Firmware for Code Blue Station (CBS), Code Pink Station (CPS), Shower Station (SHS), Toilet Station (TS), Care Assurance Station (CAS), Duty Station (DS), Emergency Station (ES)
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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