Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0570-2025 · Posted 2024-11-27

Recall StatusOpen, Classified
Product CodeIQA
Date Initiated2024-11-01
Product Quantity111 systems

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.

Firm Action

An URGENT: MEDICAL DEVICE CORRECTION letter dated 10/31/24 was sent to customers. Necessary Actions to be Taken by Clients Instructions for determining which versions of the Arial Server Software you are using are attached hereto as Exhibit C. Clients using Arial Server Software versions 11.1.4.9, 11.1.5.5, or 11.1.6.2 should: 1. Not decline previously cleared calls through the Arial App; 2. Restart the Arial Server Software if an end user has declined a previously completed call using the Arial App. After restarting the Arial Server Software, calls from the affected call point(s) will begin to be received by the Arial Server Software and the Arial Server Software will notify end users as intended. Instructions for restarting the Arial Server Software are included on Exhibit B. 3. Contact Securitas Healthcare Technical Support at 1 (800) 380-8883 to upgrade the Arial Server Software to version 11.1.7 or later. For general questions concerning this communication please contact Securitas Healthcare Technical Support at 1 (800) 380-8883. We ask that you please complete and return a copy of the acknowledgement form attached hereto as Exhibit A.

Root Cause

Software Design Change

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑