Official recall notice
FDA DeviceClass IINotable
FDA Recall: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
- Recall date
- 2026-04-22
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
119 units
Product 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.