Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Ari
Summary
The FDA issued a Class II for Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction by Securitas Healthcare LLC. Reason: Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System..
Details
Source
Device Recall
External ID
Z-0570-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 111 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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-01
Company
Lincoln, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Securitas Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Securitas Healthcare LLC have FDA actions?
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0570-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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