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Recall Observatory FDA recall evidence

Device product

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. .

Z-2031-2025

May 30, 2025

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96856
Status
Ongoing
Classification
Class I
Quantity
9899 units
Official record key
device-enforcement:Z-2031-2025

Official wording

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 information: 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 pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.