China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

This National Medical Products Administration (NMPA) document, published on April 27, 2017, details a voluntary product recall initiated by GE Vingmed Ultrasound AS, a manufacturer of medical devices. The recall was reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., the responsible unit in China, on April 14, 2017.The recall pertains to certain Color Doppler Ultrasound Diagnostic Instruments, specifically the Vivid E95, Vivid E90, and Vivid E80 models. The primary issue identified is a software-related problem where a slow response from the DICOM worklist system can lead operators to inadvertently select incorrect patient information. This error could result in patient data being displayed inaccurately during ultrasound scans and, if not corrected, images being stored under the wrong patient's record. Such a flaw carries the risk of misdiagnosis.While the recall highlights a significant patient safety concern, the manufacturer confirmed that no injuries have been reported due to this specific issue. Crucially, the affected product batches were not sold within the Chinese market, limiting direct impact in the region. The NMPA's regulatory framework requires local food and drug administration departments to supervise and manage this product in accordance with relevant regulations, and provides contact information for any inquiries.