China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

GE Vingmed Ultrasound AS, through its China distributor GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., has initiated a voluntary recall of its Color Doppler Ultrasound Diagnostic Instruments, specifically models Vivid E95, Vivid E90, and Vivid E80. The National Medical Products Administration (NMPA) published this recall notice on May 2, 2017.The primary issue identified is a software-related problem within the DICOM worklist system. If the system is slow to respond during patient searches, operators may inadvertently select the wrong patient, leading to incorrect patient information displayed during an ultrasound scan. This error could result in images being stored under the wrong patient's name, potentially causing a misdiagnosis. No patient injuries have been reported due to this issue.Under the NMPA's regulatory framework, the recall was reported, with an internal recall number FMI 76164. Despite the global recall, GE Healthcare confirmed that the specific affected batches of these ultrasound systems were neither imported into nor sold within China. Consequently, no direct product retrieval actions are required for Chinese markets for these specific batches. The NMPA's role involves requesting provincial Food and Drug Administrations to enhance their oversight and management of such products to prevent similar issues in the future.