Z-0570-2025Class II

Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile...

Name: Z-0570-2025 Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile...
Creator: Securitas Healthcare LLC
Published: 2024-11-01
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2024-11-01 / Open, Classified / root cause: software

FDA source

Securitas Healthcare LLC began a recall of 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 on 2024-11-01. FDA classified it as Class II and gives the reason as "Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0570-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-01
Posted: 2024-11-27
Recalling firm: Securitas Healthcare LLC
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
Product code: IQA System, Environmental Control, Powered
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.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 111 systems
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)