China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

The National Medical Products Administration (NMPA) published a recall notice on May 2, 2017, concerning Color Doppler Ultrasound Diagnostic Instruments manufactured by GE Vingmed Ultrasound AS. Distributed by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., the voluntary recall addresses a critical issue where operators using specific Vivid ultrasound systems (models E95, E90, E80) might select the wrong patient. This occurs when the DICOM worklist system responds slowly during searches, potentially displaying incorrect patient information during scans. If not rectified by the operator, images could be stored under the wrong patient's name, thereby creating a risk of misdiagnosis. Although no injuries have been reported, the NMPA framework prompted local food and drug administrations to enhance their management of similar products. Importantly, GE Healthcare confirmed that the affected batches of these ultrasound instruments were not sold in China. For further inquiries, stakeholders are directed to contact Wang Tong at GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.