BEUDAMED
    FDA Enforcement Class I Ongoing

    Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .

    Recall: Z-2031-2025 · Reported July 16, 2025

    Enforcement

    Recall Number
    Z-2031-2025
    Event ID
    96856
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2025
    Initiation Date
    May 30, 2025
    Classification Date
    July 9, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .

    Reason

    The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

    Code Info

    All Q-link 13 manufactured between 8/27/2013 to 2/27/2025: 1) Product Code 2010004, UDI/DI 00887761981775; 2) Product Code 2040044, UDI/DI 00887761981867; 3) Product Code 2040043, UDI/DI 00887761981850; 4) Product Code 2040045A, UDI/DI 00887761943193; 5) Product Code 2040006, UDI/DI N/A; 6) Product Code 2040007, UDI/DI N/A; 7) Product Code 2030001, UDI/DI N/A. .

    Distribution

    Worldwide

    Quantity

    9899 units