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System, Environmental Control, Powered
FDA product code IQA · Class 2 · Physical Medicine
2,998
Registered devices
38
Adverse events
17
Recalls
24
510(k) clearances
Devices with this code
CALL CORD,7700,SGL,ZET,6P,WHT,8FT — Crest Healthcare SupplyPILLOW SPKR,ELITE DIGITAL, ETKACOM — Crest Healthcare SupplyGEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.GEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.GEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.GEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.ROOMSTAT, STD SWITCH,1-BUTTON — Crest Healthcare SupplyGEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.GEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.GEN4 DIGITAL — CURBELL MEDICAL PRODUCTS, INC.Elite Pillowspeaker — Crest Healthcare SupplyGEN4 PLUS, DIRECT ACCESS — CURBELL MEDICAL PRODUCTS, INC.GEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.GEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.ASCOM — Ascom (Sweden) ABGEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.CALL CORD,LOCKING,DBL,FAR,5P,MAIBZ — Crest Healthcare SupplySTATION,PULLCORD,MOM ON/OFF SLIDE, 1G — Crest Healthcare SupplyBA 1/2 KIT,BE,P37,INL,2' — CURBELL MEDICAL PRODUCTS, INC.Amplion Care Assurance — AMPLION CLINICAL COMMUNICATIONS, INC.CALL CORD,GERIATRIC,SGL,TEK,8PD,GREY — Crest Healthcare SupplyGEN4 PLUS, DIRECT ACCESS — CURBELL MEDICAL PRODUCTS, INC.GEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.GEN4 INTERACTIVE — CURBELL MEDICAL PRODUCTS, INC.
Recent 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 |
| 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 |
| 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 notificatio |
| 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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