| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01035-1 |
| Product Name/Description |
Luminos Fusion
Cancelled ARTG 144246 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Potential risk of the footrest detaching from the patient table on Luminos Fusion.
If the footrest is not connected and locked properly to the patient table during an examination, there is a risk that it could detach, and the patient could slide off the table and be injured.
An addendum to the operator manual has been made available for customers. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The user must check that:
- The footrest is locked into position and attached firmly every time before allowing a patient to sit or stand on it.
- The two green bars on each side of the footrest are visible.
- The footrest is attached and removed when the table is horizontal.
Manufacturer is providing an addendum to operator manual together with the product defect correction letter.
The addendum contains additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling it.
This action has been closed out on 18/12/2023. |
| Contact Information |
1800 310 300 - Siemens Healthcare Pty Ltd |