China NMPA Product Recall - Fetal/Maternal Monitor

Shenzhen Genari Medical Instruments Co., Ltd. has initiated a voluntary Class III recall for its Fetal/Maternal Monitors, including models G6A, G6B, G6A Plus, and G6B Plus, within China. This action, reported on September 27, 2018, and subsequently publicized by the National Medical Products Administration (NMPA) on October 23, 2018, was prompted by identified non-compliance issues. The main violations include an incorrect label on the product's fuse and the omission of essential technical data concerning sound output levels within the instruction manual. These deficiencies affect 22 batches, totaling 124 units of the medical devices. To address these regulatory deviations and ensure adherence to medical device standards, Shenzhen Genari is required to undertake specific corrective actions. The company must rectify both the product labels and the instruction manuals to accurately reflect all necessary information. Additionally, they are mandated to promptly issue advisory notices to all users, informing them of the recall and the necessary steps to be taken to ensure product compliance and user safety.