| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00468-1 |
| Product Name/Description |
HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
ARTG Number: 187340 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
If the screws that secure the HexaPOD evo RT Couchtop are not adequately tightened during installation, they may loosen over time.
This condition has the following possible impacts:
- There may be incorrect patient repositioning if the HexaPOD evo RT Couchtop is moved.
- The HexaPOD evo RT Couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising their customers to check each screw to determine if it is loose. If any screw is loose the HexPOD evo RT system must be taken out of service and the service engineer responsible for the equipment should be contacted. The service engineer will tighten the screws to 20 Nm before the couchtop can be used. |
| Contact Information |
02 8907 1800 - Elekta Pty Ltd |