China NMPA Product Recall - Defibrillation/monitoring system

On March 3, 2020, the National Medical Products Administration (NMPA) announced a Level II voluntary recall initiated by Phisonconcile (Shanghai) Medical Devices Co., Ltd. The recall pertains to specific LIFEPAK 15 defibrillation/monitoring systems due to a significant safety concern. The core issue identified is the potential for oxidation inside the main 'shock' button, which could prevent the device from delivering a defibrillation shock when pressed. Importantly, the 'shock' button located on the defibrillator handle is not affected by this problem. Phisonconcile (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling the affected systems, registered under CFDA (Imported) 2012 No. 3212890 (Revised). This action is taken to ensure the reliability and safety of the medical devices. Further detailed information, including specific product models, specifications, and batch/serial numbers, is available in the associated Medical Device Recall Event Report Form, which provides comprehensive data for identifying affected units and facilitating proper retrieval.