| TGA Action ID |
RC-2026-RN-00190-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Arjo Tenor Mobile Passive Lift and Associated Lifting Actuators
Model Number: KHA1010-AU
Serial Numbers: P0923064, P0925710, P0935099, P0935100
Manufactured between: 06-Mar-2025 and 28-Nov-2025
Affected Components: Lifting actuators TEN.107 (also supplied within spare part RKT.560) |
| ARTG Number |
340550 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During final product testing at the Arjo manufacturing site, an anomaly in the behaviour of the lifting actuator was detected. The subsequent testing confirmed that an internal component of the actuators in the certain production batch may not meet the required mechanical strength. This could result, in the worst-case scenario, to a sudden loss of the actuator’s ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
Since this internal actuator’s malfunction cannot be identified through standard pre-use check and only becomes evident at the moment of failure, the problem is not detectable to users. The problem was identified through internal testing.
To date, no patient injury has been reported relating to this problem. |
| Instructions for Customers/Users |
1. Immediately remove all the affected Tenor lifts from service, keep them out of use until the corrective action is completed.
2. Complete and return the Customer Response Form.
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.
This action has been closed out on 12/05/2026 |
| Action Commencement Date |
17/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 002 756 - Arjo |