Class 2 Device Recall Securitas

• Date Initiated by Firm: June 20, 2024
• Date Posted: July 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2417-2024
• Recall Event ID: 94878
• Product Classification: System, environmental control, powered - Product Code IQA
• 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.
• Code Information: All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024
• FEI Number: 1929691
• Recalling Firm/ Manufacturer: Securitas Healthcare LLC; 4600 Vine St; Lincoln NE 68503-2823
• For Additional Information Contact: Garth.Jack@securitas.com; 812-371-7115
• Manufacturer 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.
• FDA Determined 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 in Commerce: 1268 units
• Distribution: US: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.