FDA Medical devices recall ·
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305… recall
- Recall number
- Z-0570-2025
- Date
- (initiated November 1, 2024)
- Company / brand
- Securitas Healthcare LLC
4600 Vine St, Lincoln, NE, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 111 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0570-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.