Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning RaySearch Laboratories AB (publ) RayStation RayPlan 7 through 2024A including some service packs [HKMD No.: 180268].
According to the TGA, 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 issue.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00269-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 9 Apr 2024
Posted on 10 Apr 2024