FDAFDA · Food and drugs·Recall number Z-1943-2024
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.
Published June 12, 2024 · Recall initiated: April 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Securitas Healthcare LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
- Lot
- Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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