China NMPA Product Recall - Pressure steam sterilizer

The National Medical Products Administration (NMPA) announced on October 17, 2019, that Getinge Sterilization AB is voluntarily recalling its steam sterilizers. This Class II recall, reported by Maikewei (Shanghai) Medical Equipment Co., Ltd., addresses a critical cybersecurity vulnerability. The primary issue identified is the potential for unauthorized remote access to the sterilizers, when connected to a network, which could lead to the alteration of essential operating parameters. Such unauthorized changes pose a significant risk to the integrity of the sterilization process and, consequently, to patient safety. The affected devices are identified by Registration Certificate No.: 20192110384. Further specifics regarding models, specifications, and batch numbers are detailed in the "Medical Device Recall Event Report." This voluntary action was initiated by the manufacturer, Getinge AB, to rectify the identified security flaw. Stakeholders, including distributors and healthcare facilities, are directed to consult the official recall documentation for detailed instructions on managing the affected products, ensuring compliance with NMPA directives, and mitigating potential risks. This recall highlights the growing importance of robust cybersecurity measures in medical devices to uphold product reliability and safeguard public health.