FDA Recall Open, Classified

Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

Recall: Z-2418-2024 · Initiated June 20, 2024

Recall

Recall Number
Z-2418-2024
Event Number
94882
Firm
Securitas Healthcare LLC
FEI Number
1929691
Product Code
IQA
Status
Open, Classified
Root Cause
Software Manufacturing/Software Deployment
Initiated
June 20, 2024
Posted
July 23, 2024
Address
4600 Vine St, Lincoln, NE, 68503-2823

Description

Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

Reason

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

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. Closely Monitor Missing Device Alerts within the Arial 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 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 1. 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 2. Clients should immediately cease using any Call Station that will not reconnect to the Arial Emergency and Nurse Call System. 2. 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 is low . 3. Consider Use of Supplementary Communication Devices or Procedures for High Risk Residents. Clients should consider enacting backup procedures, including increased room checks, or providing alternate emergency and nurse call communication means, such as a wearable pendant, for high-risk residents." "If you have distributed the product further, immediately notify your accounts that received the product identified above of this notification and ask them to contact Securitas Technical Support at 1-800-824-2996 (8:00 AM 5:00 PM CT, M-F) to obtain a response form and coordinate correction of affected devices." Securitas Healthcare is developing a firmware patch to remediate t

Distribution

US: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NE

Quantity

77 units