China NMPA Product Recall - Patient monitors, anesthesia systems

The National Medical Products Administration (NMPA) announced on March 4, 2020, an elevated recall level for patient monitors and anesthesia systems manufactured by GE Healthcare Finland Oy and Datex-Ohmeda, Inc. The recall was initially reported on November 4, 2019, by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. The primary issue stems from a potential failure of the respiratory module sensor within these medical devices. Initially designated as a Level II recall, indicating a less severe risk, the status has been upgraded to a Level I recall. This significant change signifies that the potential malfunction now poses a more serious health threat to patients. The affected products are registered under CFDA Import Medical Device Registration numbers 20143212922, 20143542837, and 20183540068. The required action involves a voluntary recall by the manufacturers, with detailed product and batch information available in the "Medical Device Recall Event Report Form." This action underscores the NMPA's commitment to ensuring the safety and efficacy of medical devices within its jurisdiction.