China NMPA Product Recall - Automated breast ultrasound diagnostic system

On April 11, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Automated Breast Ultrasound Diagnostic System. This action was overseen by the National Medical Products Administration (NMPA). The primary issue prompting the recall was an inaccuracy on the product's Chinese label, specifically an incorrect registrant's address. The affected product is registered under Certificate No. 国械注进20152230792. While specific inspection dates are not detailed, the recall announcement was publicly disclosed by the NMPA on the aforementioned date. This voluntary measure signifies the company's commitment to adhering to regulatory standards regarding medical device labeling and accuracy. As part of the required actions, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is obligated to provide detailed information on all affected models, specifications, and batches through a "Medical Device Recall Event Report Form." This ensures that all relevant parties are informed and appropriate corrective measures are implemented to rectify the labeling error, aligning with the regulatory framework governing medical devices in China.