Recall Z-1811-2026 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
| Date | Apr 10, 2026 (initiated Mar 10, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | An Urgent Medical Device Correction notification letter was sent to customers beginning 3/10/26. IMPORTANT: To mitigate the risk, all affected Tenor lifts must be removed from use immediately and should not be operated until the corrective action is completed. No additional user checks or temporary measures can reduce the risk. Arjo service personnel will carry out a required free of charge actuator replacement to restore the safe performance of the device. Solution to the issue: Arjo will implement a Field Safety Corrective Action consisting of a replacement of the affected actuator (TEN.10 |
| Quantity | 119 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.