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Arial recallZ-1943-2024 · Securitas Healthcare LLC · initiated Apr 11, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Securitas Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1943-2024
Status
Open, Classified
Initiated by the company
Apr 11, 2024
Posted by the FDA
May 31, 2024
Recalling firm
Securitas Healthcare LLC
Quantity
661 sites with mobile application user licenses
Product code
IQA
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.

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.

Code information (models, lots, serial numbers)

Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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