PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: June 12, 2024 Initiated: April 11, 2024 #Z-1943-2024

Product Description

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.

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.

Details

Recalling Firm
Securitas Healthcare LLC
Units Affected
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.
Location
Lincoln, NE

Frequently Asked Questions

What product was recalled?
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.. Recalled by Securitas Healthcare LLC. Units affected: 661 sites with mobile application user licenses.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-1943-2024.