China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its color Doppler ultrasound diagnostic systems, as announced by the National Medical Products Administration (NMPA) on June 24, 2021. The recall pertains to specific ultrasound systems, including EPIQ5, EPIQ 7, and EPIQ Elite products, which were shipped to China with software version 5.2. The primary issue identified is the unauthorized inclusion of a tumor contouring functionality within the fusion navigation feature in this software version. This particular function was not approved or intended for the corresponding software version within the Chinese market, indicating a critical discrepancy between the distributed product and regulatory requirements. The regulatory framework governing this action includes the NMPA, with the recall notice sourced from the Shanghai Municipal Drug Administration. Philips (China) proactively initiated the recall under internal document number FCO79500547 to address the non-conforming product configuration. The affected devices hold registration certificates 20193061914, 20193061919, and 20203060322. Required actions involve the comprehensive recall of all affected units, with detailed information on specific models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form." This recall underscores the importance of adhering to country-specific regulatory approvals for medical device software functionalities.