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Recall Observatory FDA recall evidence

Device 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.

Z-1943-2024

April 11, 2024

Class II

Product summary

Firm
Securitas Healthcare LLC
Event
Event 94607
Status
Ongoing
Classification
Class II
Quantity
661 sites with mobile application user licenses
Official record key
device-enforcement:Z-1943-2024

Official wording

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.

Code information: Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.