Z-2417-2024Class II

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

Name: Z-2417-2024 Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed...
Creator: Securitas Healthcare LLC
Published: 2024-06-20
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2024-06-20 / Open, Classified / root cause: software

FDA source

Securitas Healthcare LLC began a recall of Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate... on 2024-06-20. FDA classified it as Class II and gives the reason as "There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2417-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-20
Posted: 2024-07-23
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.
Product code: IQA System, Environmental Control, Powered
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.
Root cause tag: software
FDA 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 in commerce: 1268 units
Distribution: US: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada
Product codes and lots: All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2417-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2417-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-23

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)