Recall Z-1943-2024— Securitas Healthcare LLC
Class II · Ongoing
Class II FDA medical device recall by Securitas Healthcare LLC, initiated 2024-04-11. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Securitas Healthcare LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-11
- Firm location
- Lincoln, NE, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.