Arial mobile application — Class II medical device recall Z-1943-2024
Ongoing recall by Securitas Healthcare LLC, reported 2024-06-12, distributed nationwide. The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to
| Recall number | Z-1943-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Securitas Healthcare LLC, Lincoln, NE, United States |
| Recall initiated | 2024-04-11 |
| Classified | 2024-05-31 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES, FR, GB, HK, QA |
| Quantity | 661 sites |
| UPC / GTIN / UDI-DI | 00840948100963 |
| Model numbers | 54630, 54630-SMA, 54640 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1943-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.