ARJOHUNTLEIGH POLSKA Sp. Z.O.O. recalls Arjo Tenor mobile passive patient lift

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.

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.107) with a fully safe component. This correction will permanently remove the risk and restore the actuator s ability to hold the load, thereby eliminating the identified risk of sudden, uncontrolled downward movement of the lifting arm. Until the actuator is replaced, the affected Tenor lifts must remain out of service and must not be used for patient handling, as no temporary measures can ensure safe operation. The device does not require destruction or return; it will be corrected on-site through actuator replacement. Next Steps: 1. Immediately remove all the affected Tenor lifts from service, keep them out of use until the corrective action is completed, and inform all relevant staff within your facility about this Field Safety Notice. 2. Complete and return the Customer Response Form to your local Arjo representative, including details of any affected devices that have been sold or transferred to another facility. 3. Ensure availability of all affected devices for the actuator replacement and designate a facility contact person; Arjo will contact this representative to schedule the corrective action visit. 4. Maintain awareness of this notice until the corrective action has been completed for all affected units. Please note: if your facility has sold or moved the Tenor Lift please include the new facility s information in the Customer Response Form. If you have any further

• FDA enforcement recordOfficial FDA database entry for Z-1811-2026
• FDA device classification · FSAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5510The federal regulation governing this device
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