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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00627-1
Product Name/Description Tumor Localization (TumorLOC) software application used on Philips PET/CT combination diagnostic imaging systems

PET/CT system with TumorLOC supplied in Australia: GEMINI TF 64 Slice

ARTG Number: 118077
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/07/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has identified these issue with the TumorLOC software
1) When a single contour is saved in Edit Mode, TumorLOC does not save the contour in the correct location. The contour is saved in the location of the same slice where the last contour was drawn for the last Region of Interest (ROI) in the ROI list. A misplaced contour then results in a misplaced isocenter or incorrect field size.
2) When the Region of Interest (ROI) is displayed on the Beam’s Eye Viewer (BEV) in Outline mode, and the ROI colour is changed, the colour is changed in the Multi-Planar Projection (MPR) viewers but not the BEV viewers.
3) Tumor LOC-created datasets are flipped and incorrectly labelled when non-gated data is loaded along with pulmonary gated data and is used to create Intensity Projection datasets (MIP, MinIP, or AvgIP).
4) Duplicate ROI or isocenter names can be created in Tumor LOC. This duplication is only possible when using the copy feature or manually naming a ROI with the suffix Copy
Recall Action Recall for Product Correction
Recall Action Instructions A Philips Field Service Engineer will implement the Tumor LOC software upgrade to the affected system. In the interim, users are advised to implement workarounds to prevent the failure mode from occurring. This action has been closed-out on 15/08/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre