FDA recall Z-1943-2024

Securitas Healthcare LLC · Class II · 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.

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.

Key facts

Status
Ongoing
Initiation date
2024-04-11
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2024