China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

On April 27, 2017, the National Medical Products Administration (NMPA) announced a voluntary product recall initiated by GE Vingmed Ultrasound AS, a manufacturer of medical devices. The recall pertains to specific models of Color Doppler Ultrasound Diagnostic Instruments, including Vivid E95, Vivid E90, and Vivid E80.The primary concern identified, as reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., is a potential software issue. During searches, if the DICOM worklist system responds slowly, operators might inadvertently select the incorrect patient target. This could lead to the display of erroneous patient information during an ultrasound scan. If an operator fails to delete these images post-scan, they could be stored under the wrong patient's record, increasing the risk of misdiagnosis. Fortunately, no patient injuries related to this issue have been reported.According to GE Vingmed Ultrasound AS, the affected batches of these diagnostic instruments were not sold within the Chinese market. The NMPA has instructed relevant provincial, autonomous region, and municipal food and drug administration departments to oversee and manage this product in accordance with established regulations. For further inquiries or clarification, stakeholders are directed to contact Wang Tong, the designated recall contact person at GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. This proactive measure aims to mitigate potential patient safety risks associated with the identified software anomaly.