ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Class II: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
ArjoHuntleigh Polska has initiated a Class II recall for specific Arjo Tenor mobile passive patient lift models due to internal actuator components in a certain production batch failing to meet mechanical strength requirements. This defect could cause a sudden loss of load-bearing capacity, resulting in uncontrolled downward movement of the lifting arm.
This recall affects healthcare facilities and operators utilizing Arjo Tenor mobile passive patient lifts (Models KHA1000 US and KHA1010 US) and the manufacturing/quality teams responsible for these units.
The failure of a load-bearing component in a mobile patient lift represents a significant safety risk for both patients and caregivers. From a regulatory perspective, this suggests a localized manufacturing or material sourcing issue within a specific production window. Quality teams should view this as a potential failure in mechanical component verification or supplier quality control for critical load-bearing assemblies.
QA and clinical engineering teams should identify and quarantine Tenor lifts with model numbers KHA1000 US and KHA1010 US if they are part of the affected production batch. Regulatory teams should monitor for manufacturer communications regarding actuator replacement or verification of mechanical strength specifications.
Class II. Reason: An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.. Product: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US. Firm: ARJOHUNTLEIGH POLSKA Sp. z.o.o. (Komorniki N/A Poland). Status: Ongoing.
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