FDA Medical Device Recalls (openFDA)
Securitas Healthcare LLC: Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
- Recall number
- Z-2417-2024
- Recalling firm
- Securitas Healthcare LLC
- Product
- Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
- Status
- Open, Classified
- Initiated
- 2024-06-20
- Posted
- 2024-07-23
- Terminated
- not on file
- Reason
- There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Securitas Healthcare issued a recall notice on 06/19/2024 to its consignees via USPS certified mail. The notice explained the problem, potential hazard, and requested the following: "Customer Required Actions: 1. Reduce the Missing Device Timeout to 125 Minutes Hours for all Call Stations. Clients should reduce the Missing Device Timeout to 125 minutes so that a Missing Device Alert will be triggered if a Call Station fails to send a supervision message to the Arial Emergency and Nurse Call System within 125 minutes from the last supervision message. Instructions for reducing the Missing Device Timeout to 125 minutes are attached hereto as Appendix 1. 2. Closely Monitor Missing Device Alerts within the Arial Web Application and Immediately Verify Status of Missing Devices and Cease Using any Call Stations That Do Not Reconnect. Clients should closely monitor the "Missing Device Alerts within the Arial Web Application and immediately check the status of Call Stations that trigger a Missing Device Alert and replace the Call Station battery if it is low or fully depleted. Instructions for replacing the Call Station battery are attached hereto as Appendix 2. Instructions for reconnecting missing devices and confirming that the Call Stations are properly transmitting information to the Arial Emergency and Nurse Call System are attached hereto as Appendix 3. Clients should immediately cease using any Call Station that will not reconnect to the Arial Emergency and Nurse Call System. 3. Closely Monitor the Battery Status of all Call Stations in the Arial Web Client and Replace Battery if it is Low . Clients should closely monitor the Call Station Battery Status in the Arial Web Client and immediately replace the battery if it low as described in the documentation. 4. Use Supplementary Communication Devices or Procedures for High Risk Residents. Clients should enact backup procedures, including increased room checks, or providing alternate emergency
- Quantity
- 1268 units
- Distribution
- US: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada
- Lot, serial or model codes
- All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQA
- Firm FEI
- 1929691
- Firm city
- Lincoln
- Firm state
- NE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28