| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01283-1 |
| Product Name/Description |
ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
ARTG Number: 187299 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has become aware of the potential for incorrect DICOM mapping of the exported collimator or couch angles from ERGO. This would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
If the DICOM export values are not mapped correctly, it is possible that treatments could be delivered with the wrong collimator or couch angle. In the event patients were treated with the wrong collimator or couch angle, this would result in a geometric miss with the tumour being potentially under-dosed and normal structures overdosed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising users who are using MLC for dose planning in ERGO to run a verification test to ensure that the collimator and couch are rotating correctly. If the verification test fails please contact the Elekta Care Support Centre for assistance.
This action has been closed out on the 20/11/2018. |
| Contact Information |
02 8907 1800 - Elekta |