China NMPA Product Recall - Doppler fetal heart monitor

Guangzhou Chenhao Medical Device Co., Ltd. initiated a voluntary, Level III recall of its Doppler fetal heart monitors after testing revealed the products failed to meet established standards. This action was reported to the National Medical Products Administration (NMPA) on August 22, 2018, with the recall details publicly announced on October 27, 2018. The primary issues identified included non-compliant labeling, specifically the absence of a required waterproof rating label, and the omission of essential technical data regarding sound output levels in the instruction manual. The recall impacts five units of model TX188 (batch numbers T181804009, T181710106, T181804043, T181710590, T181710580) sold within China. In response, Guangzhou Chenhao Medical Device Co., Ltd. proactively contacted customer service and commenced the recall process. The company reported that waterproof rating labels (IPX1) have since been affixed to correct the labeling deficiency. For the issue concerning technical data, the company is actively communicating with a quality inspection institute for verification and to determine further handling methods, demonstrating its commitment to product quality under NMPA oversight.