# 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/cec3919f-8255-46fc-ac2d-933b6c702939/
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 04, 2019. Recall level: Level 2 Recall. On November 4, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class

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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: 2019-11-04
- Product Name: Patient monitor; Anesthesia system; CS600 MSN Anesthesia System
- Recall Level: Level 2 Recall
- Recall Reason: The O2 sensor in certain batches of CARESCAPE respiratory modules installed in some models of patient monitors or anesthesia systems may malfunction.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On November 4, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. This action was prompted by identified issues within certain CARESCAPE respiratory modules, which are components of their patient monitors and anesthesia systems. The primary concern is the potential failure of the O2 sensor within these modules. The recall specifically targets various models of patient monitors, anesthesia systems, and CS600 MSN anesthesia systems. These devices are associated with NMPA registration certificate numbers CFDA Import/Export No. 20143212922, CFDA Import/Export No. 20143542837, and CFDA Import/Export No. 20183540068. The Shanghai Food and Drug Administration also publicized this medical device recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is undertaking this voluntary recall to address the potential safety risks posed by the O2 sensor malfunction. Further details regarding the specific affected product models, specifications, and batches are available in the accompanying "Medical Device Recall Event Report Form." This measure is in line with NMPA's regulatory oversight to ensure the safety and effectiveness of medical devices in the market.

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