China NMPA Product Recall - Doppler fetal heart monitor

Guangzhou Chenhao Medical Device Co., Ltd. initiated a voluntary Class III recall of its Doppler fetal heart monitors, as reported to the National Medical Products Administration (NMPA) on August 22, 2018, and published on October 26, 2018. The recall addresses product non-compliance with regulatory standards.The primary issues identified were two-fold: a labeling non-compliance, specifically the absence of a waterproof rating label, and the failure to include technical data on sound output levels within the instruction manual. The affected products include model TX188, with specific batch numbers T181804009, T181710106, T181804043, T181710590, and T181710580, totaling 5 units.Operating under the NMPA's regulatory framework, the company has taken immediate corrective actions. They have already affixed the required IPX1 waterproof rating label to the products. Additionally, Guangzhou Chenhao Medical Device Co., Ltd. is actively engaging with a quality inspection institute to verify and update the technical data regarding sound output levels. The company has proactively contacted customers and commenced the recall process across affected regions in China. This voluntary recall emphasizes the company's commitment to addressing product deficiencies and ensuring compliance.