China NMPA Product Recall - Ultrasonic Doppler fetal heart rate monitor

Shenzhen Laijia Medical Electronics Co., Ltd. initiated a voluntary Class III recall of its Ultrasonic Doppler Fetal Heart Rate Monitors (Registration Number: 20162230182). This action was reported on July 2, 2019, and publicly announced by the National Medical Products Administration (NMPA) on July 3, 2019. The primary issue prompting the recall was the omission of essential technical data regarding sound output levels from the product's instruction manual. Affected products include 20 units of model FD-200A, specifically those with identification numbers ranging from FD3181200001 to FD3181200020. Under the NMPA's regulatory framework for medical devices, the company was required to address this deficiency. Shenzhen Laijia Medical Electronics Co., Ltd. responded by contacting customers and proactively recalling the implicated devices. Furthermore, a corrective action involved amending the instruction manual to accurately specify the sound output level technical data, ensuring compliance and providing complete product information to users. This recall demonstrates the company's commitment to product safety and adherence to regulatory standards.