China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System

Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for specific models of its color Doppler ultrasound diagnostic systems. The recall, published on May 7, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a critical software issue identified during internal product testing. The defect affects EPIQ and Affiniti series ultrasound systems running software versions 1.9 or 2.1. The primary concern is that when users employ the editing function on the Patient Data Input (PDE) screen, there is a possibility of inadvertently transferring a patient's image to a different patient's folder. This flaw poses a risk of incorrect patient data association, potentially leading to misdiagnosis or inappropriate treatment based on erroneous information. The company's required action is a comprehensive recall of the affected devices, detailed by specific registration certificate numbers. This proactive measure aims to mitigate potential patient safety risks associated with data integrity.