CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
Arial mobile application recalled by Securitas Healthcare
Securitas Healthcare is recalling Arial mobile application, distributed nationwide in the US. The recall was initiated on 11 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1943-2024
- FDA event ID
- 94607
- Recalling firm
- Securitas Healthcare, Lincoln, NE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Apr 2024
- FDA classified
- 31 May 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Apr 2024 | Recall initiated by company | |
| 31 May 2024 | Classified by FDA | +50 days |
| 12 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
Questions about this recall
Why was it 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.
Which lots are affected?
Arial Mobile v11.0.0 UDI: (01)00840948100963(10)1100.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Canada, England, Hong Kong, France, Qatar, and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Securitas Healthcare
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Arial 900 MHz Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Server recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 13 states |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 9 states |
| Device | CLASS II | Arial Water Resistant Pendant with Neck Lanyard recalled | Securitas Healthcare | Device Malfunction | Nationwide |
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