Medical device manufacturer, Varian Medical Systems, has issued a Field Safety Notice concerning 4D Integrated Treatment Console (4DITC) and TrueBeam.
Varian has identified potential discrepancies in Intensity Modulated RadioTherapy (IMRT) Complete Irradiated Area Outline (CIAO) outline visualization between treatment applications (4D Integrated Treatment Console (4DITC), AM Editor, On-Board Imager, PortalVision and TrueBeam), and treatment planning & oncology information system applications (Eclipse, ARIA, RTChart, Off-line Image Review).
According to Varian, the discrepancy is a display issue that is sometimes seen when an ad-hoc image template has been added, after the plan has been loaded on the 4DITC. None of the reported discrepancies affect the delivered dose to the IMRT field, and the planned MLC and the actual MLC used for treatment are correct. p>
According to the local supplier, the affected devices have been distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.