China NMPA Product Recall - Flow-i anesthesia machine

Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for manufacturer Maquet Critical Care AB, initiated a voluntary Level I recall for its Flow-i Anesthesia Machines (models C20, C30, C40). This action was reported to the National Medical Products Administration (NMPA) on May 6, 2016, and publicly announced on August 28, 2016. The core issue identified was a defect in the solder joints of three circuit boards within the anesthesia machines, which could lead to a short circuit. This malfunction presented a significant safety risk, potentially causing the anesthesia machine to unexpectedly restart, followed by the failure of a critical subsystem, thereby jeopardizing patient safety. The health harm level associated with this defect was assessed as high. Under the regulatory framework of the NMPA, and given the CFDA (Imported) registration number 20123542189, the company committed to several corrective actions. These included issuing a "Medical Device Recall Notice" to all users of the affected products globally and providing free replacement of the faulty circuit boards for the 31 units sold in China. This proactive measure aimed to mitigate potential risks and ensure the safe operation of these medical devices.