China NMPA Product Recall - Patient monitors, anesthesia systems

GE Healthcare Finland Oy, Datex-Ohmeda, Inc., and GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. are undertaking a voluntary recall of specific patient monitors and anesthesia systems following the identification of a critical safety issue. The primary concern stems from a potential failure within the respiratory module sensor of these medical devices, which could compromise their accurate function and patient safety. This action falls under the regulatory purview of the National Medical Products Administration (NMPA) in China. The initial recall information was disseminated on November 4, 2019, at which point it was designated as a Level II recall. However, in a significant development on March 4, 2020, the NMPA elevated the recall status to Level I. This reclassification indicates a heightened risk, signifying that the use of or exposure to the affected products carries a reasonable probability of causing serious adverse health consequences or, in severe cases, death. The escalation to a Level I recall underscores the urgency and seriousness with which the manufacturers and regulators are addressing the sensor malfunction to mitigate potential harm to patients. Detailed specifics regarding the recalled product types and registration information are documented in the 'Medical Device Recall Event Report Form' provided by the NMPA.