China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

GE Vingmed Ultrasound AS, the manufacturer, and its Chinese distributor, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., initiated a voluntary recall, indexed as FMI 76164. The National Medical Products Administration (NMPA) published this recall notice (JGXX-2017-10342) on April 28, 2017, based on a report from the Chinese distributor dated April 14, 2017. The recall concerns Color Doppler Ultrasound Diagnostic Instruments, including models Vivid E95, Vivid E90, and Vivid E80, holding Registration Certificate No.: 20173230626. The central issue stems from a potential malfunction in the DICOM worklist system. If this system responds slowly during patient searches, operators might inadvertently select an incorrect patient. This could lead to erroneous patient information being displayed during ultrasound examinations. If not rectified, images could be stored under the wrong patient

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