Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-1943-2024

U.S. FDA — Device Enforcement · United States · 2024-04-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1943-2024
Date of alert
2024-04-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Securitas Healthcare LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840948100963
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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