Arial Emergency Mobile App Restarts Cause Alert Overload and Call Failures
The Arial mobile application experiences frequent restarts on iOS 17.4 and 17.5, causing alert overload, communication failures, and offline status in healthcare facilities.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall affecting emergency communication systems in healthcare facilities. No illnesses or injuries have been reported. The hazard is a software malfunction that could impair emergency response capability. Per the rubric, recalls with no reported harm but risk-of-harm are scored at most 3.
Plain-English summary
The Arial mobile application (model numbers 54640, 54630, and 54630-SMA), a component of the Arial Emergency and Nurse Call System, is being recalled by Securitas Healthcare LLC due to a software malfunction affecting iOS 17.4 and 17.5.
When the application runs on Apple iOS 17.4 or iOS 17.5, it frequently restarts. Upon restart, the app receives all pending alarm notifications and other events at once, potentially overwhelming staff. The restarts also cause difficulty in placing and maintaining phone calls between staff members and cause the application to frequently appear offline.
The recall affects 661 healthcare facilities with mobile application user licenses. The application is distributed worldwide, including across the United States, Australia, Canada, England, Hong Kong, France, Qatar, and Spain. The affected version is Arial Mobile v11.0.0 (UDI: (01)00840948100963(10)1100).
The recalled product
- 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.
- Manufacturer
- Securitas Healthcare LLC
- Affected units
- 661
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
Distribution
Distributed nationwide across the United States.
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