China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System

Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for several models of its color ultrasound diagnostic systems. This action was announced by the National Medical Products Administration (NMPA) on February 24, 2021, with further details published on March 5, 2021, via the Shanghai Municipal Drug Administration. The recall was prompted by Philips' discovery of a potential manufacturing defect involving missing or loose screws on the control panel support arm of the EPIQ ultrasound system. This issue poses a risk that the support arm could malfunction or break if subjected to improper force, pressure, or weight, potentially compromising the system's operational integrity. The recall covers specific devices identified by multiple registration certificate numbers. Philips is proactively recalling these systems to address the safety concern, demonstrating their commitment to product quality and patient well-being under the NMPA's regulatory framework. Detailed information regarding affected product models, specifications, and batches is provided in the accompanying "Medical Device Recall Event Report Form."