China NMPA Product Recall - Breathing humidifier

HAMILTON MEDICAL AG, through its Shanghai Representative Office, initiated a Class III voluntary recall of specific models and batches of its respiratory humidifiers. This action was officially reported to the National Medical Products Administration (NMPA) on January 6, 2021. The recall stems from a software issue causing an erroneous low water level alarm to activate even when the humidifier's water tank is empty. This defect, while not directly impairing humidification, could lead to user confusion or unnecessary interventions due to an inaccurate system alert. The affected products are identified under Registration Certificate No. 20152543372. The recall is conducted under the regulatory framework of the NMPA, which hosts the official recall announcement (Index No.: JGXX-2021-10010). HAMILTON MEDICAL AG is required to address this software flaw to ensure the accuracy and reliability of its medical devices. Detailed information regarding the specific models, specifications, and batches subject to this recall is provided in an accompanying 'Medical Device Recall Event Report Form.' This proactive measure by HAMILTON MEDICAL AG aims to rectify the product issue and maintain user confidence in their respiratory humidifiers.