BEUDAMED
    FDA Recall Open, Classified

    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

    Recall: Z-0220-2024 · Initiated September 25, 2023

    Recall

    Recall Number
    Z-0220-2024
    Event Number
    93188
    Firm
    Securitas Healthcare LLC
    FEI Number
    1929691
    Product Code
    IQA
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    September 25, 2023
    Posted
    November 3, 2023
    Address
    4600 Vine St, Lincoln, NE, 68503-2823

    Description

    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

    Reason

    Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.

    Action

    Securitas Healthcare issued a recall notice to its consignees on 09/25/2023 via USPS, registered mail. The notice explained the issue, potential hazard, and requested the following actions: 1. Immediately replace Pendant battery upon Low Battery Alert 2. Customer should check Pendant battery status in Arial System application at least daily 3. Customer should check for Pendants that are no longer communicating with the Arial System at least daily This notice must be passed on to those who need to be aware within your organization. - Securitas Healthcare will be replacing all Pendants from the Affected Lots with refurbished Pendants at no cost. The notice has also been posted: https://www.securitashealthcare.com/product-advisories

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    1235 units