Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resi

FDA device recall Z-2417-2024 · posted 2024-07-23 · Open, Classified

Recall details

Recalling firm

Securitas Healthcare LLC

Reason for recall

There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.

Action taken

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

Root cause

Software Manufacturing/Software Deployment

Status

Open, Classified

Product code

IQA

Quantity affected

1268 units

Distribution

US: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada

Date initiated

2024-06-20

Date posted

2024-07-23

Location

Lincoln, NE