| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00269-1 |
| Product Name/Description |
RayStation RayPlan 7 through 2024A including some service packs
Multiple Products
ARTG 195288
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Radiation therapy treatment planning system, application program software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
In very rare cases, the calculation algorithm for the reported SSD will miss the first ROI in the beam path and instead calculate the distance to the entry point of an ROI that lies further down in the beam path, resulting in an incorrectly reported SSD. If this occurs, the reported SSD will be incorrect in the GUI, in the plan report, in DICOM export and when accessed via scripting. Both treatment beams and setup beams may be affected. It is unlikely that all beams in a beam set are affected, since the problem will only be triggered under special circumstances of ROI geometry and beam angles. The SSD saved to a beam commissioning field to be used with arbitrary photon fields in RayPhysics can also be affected.
The dose calculation uses a separate algorithm to find the patient in relation to the radiation source and is not affected by this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Actions to be Taken by the User:
· If the reported SSD is to be used for patient setup or other critical tasks, use the Measure tool to measure the distance in the patient view to make sure that the reported SSD value is correct.
· If the reported SSD value is found to be incorrect, small changes to isocenter, beam angles or the affected ROI’s geometry can be made until the correct value is achieved.
· Educate planning staff and all users about this workaround.
This problem will be resolved in the next version of RayStation/RayPlan, scheduled for market release in April 2024 (subject to market clearance in some markets). |
| Contact Information |
(02) 9006 1662 - Emergo |