System, Environmental Control, Powered
Physical Medicine · 21 CFR 890.3725
Recent MDR events
37 adverse event reports on file
- TELLIGENCE BRIDGE SOFTWAREOct 30, 2025DeathAscom Sweden Ab3008952681-2025-00001
- CISCO LI-ION POLYMERE RECHARGEABLEJun 30, 2025MalfunctionDongguan /li-ion BatteriesMW5172104
- ARIAL WIRELESS WATER-RESISTANT PENDANT ES W/NECK LANYARDJun 28, 2024InjuryInovonics Wireless Corporation1929691-2024-00002
- SECURITAS HEALTHCAREJun 28, 2024MalfunctionSecuritas Healthcare1929691-2024-00003
- AMPLION CARE ASSURANCESep 28, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00019
- AMPLION CARE ASSURANCESep 28, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00020
- AMPLION CARE ASSURANCESep 15, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00018
- AMPLION CARE ASSURANCESep 7, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00015
- AMPLION CARE ASSURANCESep 7, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00017
- AMPLION CARE ASSURANCESep 5, 2023MalfunctionAmplion Clinical Communications, Inc.3009164985-2023-00011
Event type breakdown
Recalls
17 recall events for this product code
- Securitas Healthcare LLCOpen, ClassifiedJan 8, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
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 battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Z-1031-2026 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedJan 8, 2026
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
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 battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Z-1032-2026 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedNov 27, 2024
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Z-0570-2025 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedJul 23, 2024
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate sta
There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
Z-2417-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedJul 23, 2024
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
Z-2418-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedMay 31, 2024
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nu
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 when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
Z-1943-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedNov 3, 2023
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Z-0220-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedNov 3, 2023
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Z-0221-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedNov 3, 2023
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Z-0222-2024 · View FDA record ↗ - Securitas Healthcare LLCOpen, ClassifiedMar 14, 2023
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system
The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices.
Z-1250-2023 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Gpv Americas Mexico
Zapopan Jalisco, MX
Tektone Sound & Signal Manufacturing, Inc.
Franklin, NC, US
Curbell Medical Products, Inc.
ORCHARD PARK, NY, US
Aeroscout, Ltd.
Ness Ziona Central, IL
Chowsons International Inc
Tainan City, TW
Cyient Dlm Limited
HYDERABAD Telangana, IN
Aiphone Co., Ltd., Toyota Factory
Toyota Aichi, JP
Accessibility Services, Inc.
Homosassa, FL, US
Crest Electronics Inc.
DASSEL, MN, US
Ascom Sweden Ab
Goteborg Vastra Gotaland, SE
Aiphone Corporation
Redmond, WA, US
Securitas Healthcare Llc
LINCOLN, NE, US
Auspic Electronic
Binh Duong Ward, Ho Chi Minh City, VN
Gpv Asia (thailand) Co.,ltd.
Muang Samutprakarn Samut Prakan, TH
Ascom Us, Inc.
Morrisville, NC, US
Yuiyn Hoo Industrial Limited
Dong Guan City Guangdong, CN
Control Bionics Inc.
Milford, OH, US
Umano Medical Inc
L Islet Quebec, CA
510(k) clearances
24 clearances for this product code
- Prentke Romich Co.Jun 27, 1996
K961306 · DELTATALKER WITH INFRARED
- Teledyne Brown EngineeringNov 21, 1995
K953905 · IMPERIUM
- Apt Technology, Inc.Oct 31, 1995
K953937 · LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM
- Apt Technology, Inc.Sep 11, 1995
K943244 · DEUCE
- Prentke Romich Co.Feb 21, 1995
K944585 · SCANNING DIRECTOR
- Trac Medical, Inc.Oct 17, 1994
K944345 · BEDSIDE BUTLER
- Interactive Technologies, Inc.Apr 29, 1994
K940223 · LEARN MODE WATERPROOF PENDANT PANIC BUTTON
- Zygo Industries, Inc.Mar 26, 1993
K926029 · INFRA-LINK