FDA DeviceClass IINotable

FDA Recall: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

Date: 2026-04-22
Brand: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

119 units

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