China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

The National Medical Products Administration (NMPA) issued a recall notice on April 27, 2017, regarding Color Doppler Ultrasound Diagnostic Instruments, specifically Vivid E95, E90, and E80 models. The recall was voluntarily initiated by the manufacturer, GE Vingmed Ultrasound AS, with its Chinese distributor, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., reporting the issue on April 14, 2017. The primary concern is a software flaw where a slow DICOM worklist system response can cause operators to inadvertently select and store ultrasound images under incorrect patient information. This error could potentially lead to misdiagnosis. However, the manufacturer confirmed that the affected product batches were not imported or sold within China. Despite no reported injuries, the NMPA mandates ongoing supervision and management of this product, ensuring compliance with regulatory standards, particularly given the potential for misdiagnosis in other affected regions like the USA, Canada, and the European Economic Area.