China NMPA Product Recall - X-ray computed tomography equipment

On April 17, 2020, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for specific batches of its Brilliance iCT X-ray computed tomography equipment. This action was taken in collaboration with the National Medical Products Administration (NMPA) after an internal review by Philips identified a manufacturing deviation. The review revealed that the torque of the fixing bolts connecting the cooling device to the rotor in certain units of the Brilliance iCT equipment might not meet Philips' internal quality specifications. This potential issue, while categorized as unlikely to cause severe adverse health consequences, prompted a proactive response from Philips to maintain product quality and patient safety standards. The company promptly reported this finding to the NMPA and proceeded with the recall to rectify the deviation. Comprehensive details, including specific models, specifications, and affected batch numbers, were provided in the associated Medical Device Recall Event Report Form. This voluntary recall highlights Philips' dedication to stringent quality control and adherence to the regulatory guidelines overseen by the NMPA.