China NMPA Product Recall - Patient monitor; Anesthesia system; CS600 MSN Anesthesia System

On November 4, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. This action was prompted by identified issues within certain CARESCAPE respiratory modules, which are components of their patient monitors and anesthesia systems. The primary concern is the potential failure of the O2 sensor within these modules. The recall specifically targets various models of patient monitors, anesthesia systems, and CS600 MSN anesthesia systems. These devices are associated with NMPA registration certificate numbers CFDA Import/Export No. 20143212922, CFDA Import/Export No. 20143542837, and CFDA Import/Export No. 20183540068. The Shanghai Food and Drug Administration also publicized this medical device recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is undertaking this voluntary recall to address the potential safety risks posed by the O2 sensor malfunction. Further details regarding the specific affected product models, specifications, and batches are available in the accompanying "Medical Device Recall Event Report Form." This measure is in line with NMPA's regulatory oversight to ensure the safety and effectiveness of medical devices in the market.