China NMPA Product Recall - Ventilator

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific ventilators (Registration Certificate No.: 20173541051) on December 5, 2018. This action, reported by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a critical safety concern. The company identified that the inspiratory safety protection device, specifically those utilizing a 15mm conical female connector, could potentially disconnect from the breathing circuit. This detachment poses a significant risk of insufficient oxygenation for patients undergoing ventilation, thereby increasing the likelihood of hypoxia. The recall aims to mitigate this patient safety risk by removing the affected products from distribution. Details regarding the precise models, specifications, and batches of the impacted ventilators were provided in an attached Medical Device Recall Event Report Form.