| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00708-1 |
| Product Name/Description |
Monaco RTP System (Radiation Treatment Planning System Software)
Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00
ARTG Number: 186856 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
This issue affects Monaco Releases that have been upgraded to 3.20.00 (from 3.10.00) and 3.30.00 (from 3.20.00) and a sample couch parameter file has been edited and saved prior to the upgrade. If the sample couch parameter files are edited (post upgrade), the densities altered, and "Save" is selected, the sample files will be updated with these new, user defined densities. If these changes are saved under the original name, when a software upgrade is loaded, the modified couch densities in these sample files will be overwritten with the default value of 1.000. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is providing work around instructions for users to follow as an interim measure, Elekta is currently working on a preventative action, and will provide further information once this has been determined. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |