Z-1943-2024Class II

Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple...

Name: Z-1943-2024 Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple...
Creator: Securitas Healthcare LLC
Published: 2024-04-11
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2024-04-11 / Open, Classified

FDA source

Securitas Healthcare LLC began a recall of 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... on 2024-04-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1943-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-11
Posted: 2024-05-31
Recalling firm: Securitas Healthcare LLC
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.
Product code: IQA System, Environmental Control, Powered
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.
FDA root cause: Under Investigation by firm
Action: Phone calls were initiated on 4/11/2024 and the sales teams used the information in a FAQ document during the call. The FAQ explained what happened, what products are affected, the potential hazards, whether the application will still be operational, what to do if the customer has or has not upgraded their operating system to Apple iOS 17.4 or later, can the Arial Server or workstations still be used effectively, does the issue affect Android mobile devices, does the issue affect any other functionality of Arial Emergency and Nurse Call System, who can the customer contact for more information, and when will the update be available. Recall letters were dated and issued on 4/11/2024 via certified mail. The letter described the issue, informed the customer this communication does not apply to users using mobile devices with an Android operating system, provided information on the affected product, the hazard involved, and the necessary actions to take. The actions were: 1. For users that have not already upgraded their mobile devices utilizing Apple iOS 17.3 or earlier to Apple iOS 17.04 or Apple iOS 17.5, the customer should not upgrade their operating system and disable automatic updates. 2. For clients that have already upgraded their mobile device operating system to Apple iOS 17.4, they were informed there is no current mitigation to the issue and the recalling firm is working to identify and develop a mitigation and permanent solution. Alerts for alarms and other events will continue to be received by the Arial Server and Arial workstations. In the interim, Securitas Healthcare suggests that users use the Arial Server or Arial workstations to view and respond to notifications and system warnings. Users with Apple iOS 17.4 were instructed to not upgrade their operating system to Apple iOS 17.5 and disable automatic updates. Instructions were enclosed on disabling automatic updates. 3. For users that have already upgraded their mobile device operati
Quantity in commerce: 661 sites with mobile application user licenses
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
Product codes and lots: Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)