| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00822-3 |
| Product Name/Description |
Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)
Machine Range: 105345 to 151675 (inclusive),
ARTG Number: 111760 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Elekta Digital Linear Accelerator Gantry Base wheel bolts have been found to become loose and fail in some instances. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is informing customers that all gantry base wheel bolts should be checked and they should be replaced if found to be showing signs of fatigue. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |