FDA recall Z-0570-2025

Securitas Healthcare LLC · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-11-01
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2025