ClearanceBrief
Recall Z-2417-2024 ยท IQA System, Environmental Control, Powered

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.

DateJul 23, 2024 (initiated Jun 20, 2024)
StatusOpen, Classified
ReasonThere is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
Root causeSoftware Manufacturing/Software Deployment
ActionSecuritas 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
Quantity1268 units
DistributionUS: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.