Recall Z-0570-2025 ยท IQA System, Environmental Control, Powered
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
| Date | Nov 27, 2024 (initiated Nov 1, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 111 systems |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.