System, Environmental Control, Powered
FDA product code IQA · Class II (moderate risk) · 21 CFR 890.3725 · Physical Medicine
24510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Rehab Technology, Inc. 3
- Prentke Romich Co. 3
- Apt Technology, Inc. 2
- J. H. Emerson Co. 2
- Baylor Biomedical Services 2
- Teledyne Brown Engineering 1
- Possum, Inc. 1
- Trac Medical, Inc. 1
- Interactive Technologies, Inc. 1
- Zygo Industries, Inc. 1
- Hill-Rom, Inc. 1
- Zofcom, Inc. 1
- Silent Call Corp. 1
- Quartet Technology, Inc. 1
- Intl. Management Services, Inc. 1
- Independent Living, Inc. 1
- Qa Alert Systems 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961306 | Deltatalker with InfraredIQA · Traditional | Prentke Romich Co. | 06/27/1996SE |
| K953905 | ImperiumIQA · Traditional | Teledyne Brown Engineering | 11/21/1995SE |
| K953937 | Liaison Computer Access & Environmental Control SystemIQA · Traditional | Apt Technology, Inc. | 10/31/1995SE |
| K943244 | DeuceIQA · Traditional | Apt Technology, Inc. | 09/11/1995SE |
| K944585 | Scanning DirectorIQA · Traditional | Prentke Romich Co. | 02/21/1995SE |
| K944345 | Bedside ButlerIQA · Traditional | Trac Medical, Inc. | 10/17/1994SE |
| K940223 | Learn Mode Waterproof Pendant Panic ButtonIQA · Traditional | Interactive Technologies, Inc. | 04/29/1994SE |
| K926029 | Infra-LinkIQA · Traditional | Zygo Industries, Inc. | 03/26/1993SE |
| K921528 | Hill-Rom Patient Environmental Control SystemIQA · Traditional | Hill-Rom, Inc. | 04/20/1992SE |
| K911101 | Tonguetouch Keypad and Zofcom Control SystemIQA · Traditional | Zofcom, Inc. | 04/25/1991SE |
| K902664 | Hospital/Home Environmental Control SYST/HECS-1IQA · Traditional | Prentke Romich Co. | 07/25/1990SE |
| K901028 | Environmental Control Unit Model 7000IQA · Traditional | Baylor Biomedical Services | 03/13/1990SE |
| K900969 | Remote Control SwitchIQA · Traditional | Baylor Biomedical Services | 03/13/1990SE |
| K890596 | Med-A-Call Assist DeviceIQA · Traditional | Silent Call Corp. | 03/14/1989SE |
| K881634 | Simplicity Series 5IQA · Traditional | Quartet Technology, Inc. | 05/17/1988SE |
| K873612 | Imsi, Vital CallIQA · Traditional | Intl. Management Services, Inc. | 11/23/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | J. H. Emerson Co. | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | J. H. Emerson Co. | 09/24/1987SE |
| K851740 | Ezzie SystemIQA · Traditional | Independent Living, Inc. | 07/15/1985SE |
| K850314 | Television Control Option 1220IQA · Traditional | Rehab Technology, Inc. | 04/25/1985SE |
| K850313 | Television Control Option 1219IQA · Traditional | Rehab Technology, Inc. | 04/25/1985SE |
| K840808 | Ecu 1218IQA · Traditional | Rehab Technology, Inc. | 03/19/1984SE |
| K832057 | Nurse Call ButtonIQA · Traditional | Qa Alert Systems | 07/12/1983SE |
| K770028 | Environmental Control SystemsIQA · Traditional | Possum, Inc. | 01/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1032-2026 Class II | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may… | Securitas Healthcare LLC | 12/08/2025Open, Classified |
| Z-1031-2026 Class II | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may… | Securitas Healthcare LLC | 12/08/2025Open, Classified |
| Z-0570-2025 Class II | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the…Certain software versions will not notify end users of calls initiated by call points with the Arial… | Securitas Healthcare LLC | 11/01/2024Open, Classified |
| Z-2418-2024 Class II | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse…This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature… | Securitas Healthcare LLC | 06/20/2024Open, Classified |
| Z-2417-2024 Class II | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated…There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature… | Securitas Healthcare LLC | 06/20/2024Open, Classified |
| Z-1943-2024 Class II | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple…The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app… | Securitas Healthcare LLC | 04/11/2024Open, Classified |
| Z-0222-2024 Class II | Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile…Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency… | Securitas Healthcare LLC | 09/25/2023Open, Classified |
| Z-0221-2024 Class II | Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile…Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency… | Securitas Healthcare LLC | 09/25/2023Open, Classified |
| Z-0220-2024 Class II | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile…Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency… | Securitas Healthcare LLC | 09/25/2023Open, Classified |
| Z-1250-2023 Class II | Arial mobile application, model #54630 and #54640 for Android devices downloaded from…The mobile application for Android devices downloaded from the Google Play Store do not load per… | Securitas Healthcare LLC | 02/06/2023Open, Classified |
| Z-0497-2022 Class II | Senior Living Arial Emergency and Nurse Call SystemsSystems are not alarming due to increased memory consumption. | Stanley Security Solutions Inc | 11/17/2021Open, Classified |
| Z-1996-2019 Class II | STANLEY Healthcare Arial 54315 Network ManagerSTANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been… | Stanley Security Solutions Inc | 06/14/2019Terminated |
| Z-0486-2019 Class II | Ascom Telligence Nurse Call SystemThere is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the… | Ascom (US) Inc. | 11/02/2018Open, Classified |
| Z-1375-2013 Class II | QuietCare. Intended for use in monitoring the environmental conditions and activity…Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Intel-GE Care Innovations LLC | 04/04/2013Terminated |
| Z-1374-2013 Class II | QuietCare-Networked. Intended for use in monitoring the environmental conditions and…Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Intel-GE Care Innovations LLC | 04/04/2013Terminated |
| Z-1703-2012 | Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 --…On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30.… | Intel-GE Care Innovations LLC | 08/01/2011Terminated |
| Z-1615-2012 | QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA)…The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage… | Intel-GE Care Innovations LLC | 07/30/2011Terminated |