Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a
Summary
The FDA issued a Class II for Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utili by Securitas Healthcare LLC. 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 n.
Details
Source
Device Recall
External ID
Z-1943-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
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.
Lot/Code Info: Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
Quantity Affected: 661 sites with mobile application user licenses
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-11
Company
Lincoln, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Securitas Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Securitas Healthcare LLC have FDA actions?
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1943-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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