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Recall Observatory FDA recall evidence

Device product

Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.

Z-2032-2025

May 30, 2025

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96856
Status
Ongoing
Classification
Class I
Quantity
9839 units
Official record key
device-enforcement:Z-2032-2025

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 LikoScale Adapter Kits manufactured between 8/27/2013 to 2/27/2025

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.