Medical Device
Manufacturing
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Z-2418-2024Class II

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

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

Securitas Healthcare LLC began a recall of Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station on . FDA classified it as Class II and gives the reason as "This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-2418-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Securitas Healthcare LLC
Product
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Product code
IQA System, Environmental Control, Powered
Reason for recall
This is a risk that alarms will not be received by the Arial Wireless Nurse 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. 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
Quantity in commerce
77 units
Distribution
US: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NE
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-2418-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2418-2024Class IIOngoingVoluntary: Firm initiated