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Recall Observatory FDA recall evidence

Device product

Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application

Z-0570-2025

November 01, 2024

Class II

Product summary

Firm
Securitas Healthcare LLC
Event
Event 95652
Status
Ongoing
Classification
Class II
Quantity
111 systems
Official record key
device-enforcement:Z-0570-2025

Official wording

Reason: Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

Code information: All Systems using Arial Server Software versions 11.1.4 through 11.1.6 in conjunction with the Arial Mobile Application or Arial Care Giver Application

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions will