Medical device manufacturer, Philips Healthcare, has issued a Field Safety Notice on their TumorLOC software application in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, and GEMINI TF Big Bore systems.
According to the manufacturer, TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list. This occurs when using the Save button, Exit button or SendToLaser button.
Philips further explained that there may be a risk of unintended radiation to healthy tissue and failure to deliver radiation to target lesion. However, this is highly unlikely to occur because TumorLOC does not have the capability to create treatment plans that include dose information.
As confirmed by the local supplier, the affected product has been distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.