FDA Medical Device Recalls (openFDA)
Securitas Healthcare LLC: 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
- Recall number
- Z-0570-2025
- 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
- Status
- Open, Classified
- Initiated
- 2024-11-01
- Posted
- 2024-11-27
- Terminated
- not on file
- Reason
- Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
- 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
- 111 systems
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQA
- Firm FEI
- 1929691
- Firm city
- Lincoln
- Firm state
- NE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28