# China NMPA Product Recall - Aespire and Aestiva anesthesia systems, anesthesia machines

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/ed99a8a0-d25d-4b80-8fdc-0c5c919d62e3/
Source feed: China

> China NMPA product recall for Aespire and Aestiva anesthesia systems, anesthesia machines by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published August 27, 2019. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling anesthesia machines, anesthesia systems, and related products.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-08-27
- Product Name: Aespire and Aestiva anesthesia systems, anesthesia machines
- Recall Level: Level 2 Recall
- Recall Reason: Some Aespire and Aestiva anesthesia systems, when connected to hospital networks, are theoretically vulnerable to cyberattacks if the terminal servers lack security. If this occurs without proper clinical intervention, it could theoretically affect oxygen supply or ventilation for anesthetized patients.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall on August 27, 2019, for specific models of its Aespire and Aestiva anesthesia systems. This action was prompted by the discovery of a critical cybersecurity vulnerability. The company identified that when these anesthesia systems are integrated into hospital networks, they could, in the absence of robust security safeguards for the terminal server, become susceptible to cyberattacks. A significant concern arising from this vulnerability is the theoretical potential for such attacks to disrupt the oxygen supply or ventilation functions of the systems, thereby posing a direct risk to anesthetized patients if not immediately countered by clinical intervention. The recall initiative was formally reported to the National Medical Products Administration (NMPA), underscoring the company's compliance with national medical device regulations. This preventative measure is essential to address the identified safety concern and ensure patient well-being. Comprehensive details regarding the specific affected product models, specifications, and batch numbers are provided in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/