China NMPA Product Recall - Color Doppler ultrasound diagnostic instrument

GE Healthcare (China) Co., Ltd. initiated a Class III voluntary recall for 51 units of its LOGIQ V5 Expert model color Doppler ultrasound diagnostic instruments distributed across China. This recall was formally reported to the National Medical Products Administration (NMPA) on September 18, 2017, and subsequently published on September 20, 2017. The core issue identified by GE Healthcare was an administrative error: incorrect medical device registration certificate numbers were printed on the product labels and user manuals of specific batches. The company emphasized that this labeling discrepancy is unrelated to the safety or functional performance of the ultrasound devices themselves. The recall was prompted by a commitment to ensure full compliance with Chinese medical device regulations, which require accurate registration information on all product documentation. To rectify the situation, GE Healthcare is implementing a two-pronged corrective action plan. First, affected customers are being directly informed of the issue through official email communications. Second, GE Healthcare engineers are being dispatched to customer locations to perform on-site corrections, which involve replacing the inaccurate labels and manuals with correct versions at no cost to the users. This proactive measure ensures that all documentation aligns with the official NMPA registration details.