China NMPA Product Recall - Positron Emission Tomography/X-ray Computed Tomography Imaging System (PET/CT)

On June 30, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Philips Medical Systems (Cleveland), Inc. concerning specific models of its PET/CT Imaging Systems. The recall stems from a critical safety concern identified with the monitor bracket assembly. It was determined that severe wear on the monitor bracket assembly axis, if left unaddressed, could result in the detachment of the monitor bracket, posing a significant safety risk to both patients and operators during use. Philips (China) Investment Co., Ltd. reported this issue to the NMPA, leading to the voluntary recall action by the manufacturer, Philips Medical Systems (Cleveland), Inc. This measure is taken to ensure the continued safety and efficacy of their medical devices in accordance with established regulatory frameworks. The specific details regarding the affected product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form" attached to the NMPA's announcement. This proactive recall demonstrates the company's commitment to addressing potential product deficiencies to safeguard public health and maintain product quality standards.