Class 2 Device Recall Arial mobile application

• Date Initiated by Firm: April 11, 2024
• Date Posted: May 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1943-2024
• Recall Event ID: 94607
• Product Classification: System, environmental control, powered - Product Code IQA
• Product: Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
• Code Information: Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
• FEI Number: 1929691
• Recalling Firm/ Manufacturer: Securitas Healthcare LLC; 4600 Vine St; Lincoln NE 68503-2823
• For Additional Information Contact: Ameya Oke; 812-371-7115
• Manufacturer Reason for Recall: The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
• FDA Determined Cause: Under Investigation by firm
• Action: Phone calls were initiated on 4/11/2024 and the sales teams used the information in a FAQ document during the call. The FAQ explained what happened, what products are affected, the potential hazards, whether the application will still be operational, what to do if the customer has or has not upgraded their operating system to Apple iOS 17.4 or later, can the Arial Server or workstations still be used effectively, does the issue affect Android mobile devices, does the issue affect any other functionality of Arial Emergency and Nurse Call System, who can the customer contact for more information, and when will the update be available. Recall letters were dated and issued on 4/11/2024 via certified mail. The letter described the issue, informed the customer this communication does not apply to users using mobile devices with an Android operating system, provided information on the affected product, the hazard involved, and the necessary actions to take. The actions were: 1. For users that have not already upgraded their mobile devices utilizing Apple iOS 17.3 or earlier to Apple iOS 17.04 or Apple iOS 17.5, the customer should not upgrade their operating system and disable automatic updates. 2. For clients that have already upgraded their mobile device operating system to Apple iOS 17.4, they were informed there is no current mitigation to the issue and the recalling firm is working to identify and develop a mitigation and permanent solution. Alerts for alarms and other events will continue to be received by the Arial Server and Arial workstations. In the interim, Securitas Healthcare suggests that users use the Arial Server or Arial workstations to view and respond to notifications and system warnings. Users with Apple iOS 17.4 were instructed to not upgrade their operating system to Apple iOS 17.5 and disable automatic updates. Instructions were enclosed on disabling automatic updates. 3. For users that have already upgraded their mobile device operati
• Quantity in Commerce: 661 sites with mobile application user licenses
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
• 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.