Recall Z-1811-2026— ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class II · Ongoing
Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2026-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US. 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..
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-10
- Firm location
- Komorniki, N/A, Poland
Product description
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.