| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01023-1 |
| Product Name/Description |
MONACO, version 5.10.00 and above
(Radiation therapy treatment planning system)
ARTG number: 215960 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
1) In version 5.10.01, the Isodose Control 100% isodose value (second in the list) was linked to the Dose Normalisation (DN) value so users would always have a known normalisation value linked to 100% when in relative mode. When the 100% isodose value is edited on the isodose control, the DN is automatically updated. If the user does not notice this update & then rescales to a relative isoline & does not read the DN value displayed on the rescale bar, the rescale could be other than intended.
2) In version 5.10.00 or greater, when the user optimises, then changes the bolus assignment of the beams, and then selects “Calculate” (not “Optimize” again), the bolus assignment to beams can get scrambled. Beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. The dose distribution and Monitor Units are incorrect. Skin doses could either be higher of lower than intended and this increase or decrease in dose could exceed 5%. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1) The workaround is to only assign one value greater than 100% as the system is defaulted so the 100% isodose line and dose normalisation values are not affected. When rescaling, the dose normalisation value is displayed next to the re-scale value being entered by the user.
2) There is no workaround using the described workflow. However, the problem can be avoided by changing any bolus assignment before optimisation.
Both problems will be resolved in Monaco Patch Release 5.10.02. This action has been closed-out on 22/08/2016. |
| Contact Information |
02 8907 1800 - Elekta |