Medical Device Recall: 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.
Securitas Healthcare LLC · April 11, 2024
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
States Affected
NATIONWIDE
Quantity Affected
661 sites with mobile application user licenses
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1943-2024
Status: ongoing
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