China NMPA Product Recall - X-ray computed tomography (CT) equipment; X-ray computed tomography equipment; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall on July 8, 2019, for several models of its X-ray Computed Tomography (CT) and Positron Emission Tomography (PET)/CT equipment. This action, reported under the regulatory oversight of the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration, was prompted by the detection of a specific technical issue: phase marker deviation in step-scan images. The affected product lines include Brilliance CT, Brilliance iCT, Brilliance ICT SP, Ingenuity CT, Ingenuity TF, IQon Spectral CT, and Vereos PET/CT systems. These devices are used for medical imaging and diagnostics. A "Class III" recall signifies that the probability of adverse health consequences from the use of the product is remote. Philips (China) is undertaking this recall to address the identified anomaly and maintain product quality and patient safety. Customers with the specified equipment models are directed to consult the "Medical Device Recall Event Report Form" for detailed information regarding affected specifications and batches, and to understand the necessary corrective actions as part of the recall process. This proactive measure aligns with regulatory expectations for medical device manufacturers.