China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (CT) system

Philips (China) Investment Co., Ltd., in coordination with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II medical device recall on July 16, 2015. This action, reported to the National Medical Products Administration (NMPA), addresses critical software errors identified in the Tumor LOC application within their GEMINI Positron Emission Tomography and X-ray Computed Tomography (PET/CT) systems. The primary issue is a defect in the Tumor LOC software, specifically impacting the accurate maintenance of profiles during editing, incorrect display of Regions of Interest (ROI) colors in outline mode, potential left-to-right flipping of intensity projection datasets, and improper copying of ROI/isocorner point names. These malfunctions affect several models, including the Gemini TF Big Bore and Gemini TF, with five units imported and sold in China being directly impacted, as part of a global recall. Under the NMPA's regulatory framework, Philips has implemented corrective actions. The company has formally notified all affected users about these issues and has initiated Field Corrective Actions (FCO 88200497). Philips field engineers are actively contacting customers to schedule and perform necessary software upgrades to rectify the identified defects. Importantly, no patient injuries related to these software errors have been reported worldwide to date.