FDA Enforcement
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.
Recall: Z-1943-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-1943-2024
- Event ID
- 94607
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Securitas Healthcare LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 12, 2024
- Initiation Date
- April 11, 2024
- Classification Date
- May 31, 2024
- Address
- 4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States
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
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 Info
Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
Quantity
661 sites with mobile application user licenses