| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00083-2 |
| Product Name/Description |
Apex (Multileaf collimator used with Elekta linear accelerators)
ARTG Number: 186855 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
If the Apex collimator has not been correctly installed on the radiation head and the user use the TOUCHGUARD button to override the touchguard inhibit and rotate the gantry, the Apex collimator can disconnect form the radiation head. This can occur because a fault condition that shows that the Apex collimator was not attached correctly is bypassed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are requested to include additional safety information provided with the customer letter in the instructions for use. The safety information requests users to ensure that they do not override the touchguard inhibit or rotate the gantry after installing the Apex collimator. The safety information also informs users that the View Restrictions dialogue box may not show the touchguard inhibit restriction if there are other restrictions present. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |