| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00333-1 |
| Product Name/Description |
RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)
when used with photon Collapsed Cone dose calculation
Build Number: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, or 7.0.0.19
ARTG Number: 195288
(Emergo Asia Pacific T/a Emergo Australia - Radiation therapy treatment planning system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
The field measure calculation may be incorrect for certain LINAC types. The error can affect beam commissioning of machines with the MLC closer to the source than both x- and y-jaws (e.g., Elekta Synergy with MLCi/MLCi2). The error can also affect the dose calculation in treatment planning with the same type of machines as well as machines with fixed jaws (e.g., Elekta BM and Vero), for some specific types of treatment plans.
If the Elekta Synergy with MLCi/MLCi2, or a LINAC with similar collimator setup, is commissioned with measurement conditions ‘MLC only’, it may lead to errors in the Output Factor Corrections (OFCs) and dose normalisation of the beam model. This is expected to result in a systematic error of 0 to 2% for most treatment plans and typical variations in the beam model OFCs.
To date, there have been no reports of injury as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Emergo is advising users:
· Do not use ‘MLC only collimated’ to set output factor corrections (OFCs) in beam modelling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use ´Jaws and MLC collimated´.
· Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm.
This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018.
This action has been closed out on 18/10/2019 |
| Contact Information |
02 9006 1662 - Emergo Australia |