Z-0570-2025 Class II Ongoing
FDA device recall Z-0570-2025 was initiated by Securitas Healthcare LLC on November 1, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 111 systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- November 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 systems
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
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
Code Information
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