# China NMPA Product Recall - Patient monitor; Anesthesia system; CS600 MSN Anesthesia System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/e8825d63-0eab-4cb4-a4e6-87efa657103d/
Source feed: China

> China NMPA product recall for Patient monitor; Anesthesia system; CS600 MSN Anesthesia System by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published November 11, 2019. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on November 11, 2019, that GE Healthca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling patient monitors, anesthesia systems, and the CS600 MSN anesthesia system.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-11-11
- Product Name: Patient monitor; Anesthesia system; CS600 MSN Anesthesia System
- Recall Level: Level 2 Recall
- Recall Reason: A problem exists with the O2 sensor in certain batches of CARESCAPE respiratory modules installed in certain models of patient monitors or anesthesia systems.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on November 11, 2019, that GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has initiated a voluntary Class II recall for several of its medical devices. The affected products include specific models of patient monitors, anesthesia systems, and CS600 MSN Anesthesia systems, identified by registration certificate numbers such as CFDA (Imported) 2014 No. 3212922, (Imported) 2014 No. 3542837, and CFDA Import Registration No. 20183540068. The primary issue prompting this recall is the recent discovery of a problem with the O2 sensors found in certain batches of CARESCAPE respiratory modules, which are critical components of these life-supporting systems. The document does not specify any inspection dates related to this issue, rather it focuses on the company's proactive recall. Under the regulatory framework of the NMPA, the company is required to undertake specific actions. These include a voluntary recall to mitigate potential risks and the submission of a detailed "Medical Device Recall Event Report Form." This form must provide comprehensive information on all affected models, their specifications, and batch numbers. This action ensures transparent communication and effective management of the recall process, underscoring the commitment to product safety and regulatory compliance.

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