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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning RaySearch Laboratories RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B including service packs [HKMD No.: 180268].
According to the MHRA, the manufacturer has identified issues with DICOM export from the Virtual Simulation module and issues with import of Virtual Simulation plans in RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs. The user must be aware of the information provided to avoid incorrect treatment delivery.
For further information, please visit https://mhra-gov.filecamp.com/s/d/tP44w4bn5QXOGlET
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Feb 2023