China NMPA Product Recall - Patient monitor, clinical monitor

Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a voluntary Level II recall of its patient and clinical monitors on March 15, 2019, as announced by the National Medical Products Administration (NMPA). The recall stems from a critical safety concern related to the incorrect installation direction of the products' AC power cords. This installation defect poses a significant risk: liquid may enter the power supply unit, potentially leading to an electrical short circuit. Such a malfunction could result in fire, presenting a serious hazard to users and patients. The company proactively reported this issue and is implementing the recall to mitigate potential risks. This action falls under the regulatory oversight of the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. Edwards (Shanghai) Medical Supplies Co., Ltd. is required to identify and retrieve all affected units from the market. Specific details regarding the models, specifications, and batch numbers of the recalled devices are provided in a "Medical Device Recall Event Report Form," which accompanies the official announcement. This voluntary recall demonstrates the company's commitment to product safety and compliance with regulatory standards.