Recall Z-1943-2024 ยท IQA System, Environmental Control, Powered
Securitas Healthcare LLC
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.
| Date | May 31, 2024 (initiated Apr 11, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 informatio |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.