| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00667-1 |
| Product Name/Description |
All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads
ARTG Number: 111760 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has advised that some Digital Accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta are asking users to check all affected machines against the default auto-tracking settings. A software update will be provided as a permanent fix. This action has been clsoed-out on 01/02/2016. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |