# China NMPA Product Recall - Anesthesia system (Aisys CS2, Avance CS2, Aestiva/5 MRI)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/1310ad38-5694-42e0-804f-6d0ac599f14d/
Source feed: China

> China NMPA product recall for Anesthesia system (Aisys CS2, Avance CS2, Aestiva/5 MRI) by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published September 22, 2021. 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 systems.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2021-09-22
- Product Name: Anesthesia system (Aisys CS2, Avance CS2, Aestiva/5 MRI)
- Recall Level: Level 2 Recall
- Recall Reason: Recently, it was discovered that a small number of flow sensors manufactured before June 2021 may have damaged tubing (small holes or cuts). This problem could lead to leaks that cause the anesthesia system to display incorrect tidal volumes, potentially resulting in over-ventilation of the patient.
- 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 of certain anesthesia systems on September 22, 2021. This action, reported by the Shanghai Municipal Drug Administration and under the oversight of the National Medical Products Administration (NMPA), addresses a significant product concern. The main issue stems from flow sensor tubing manufactured before June 2021, which may have sustained damage, such as small holes or cuts. This defect can lead to leakage, causing the anesthesia system to display incorrect tidal volume measurements. The potential consequence of this malfunction is patient over-ventilation, posing a serious safety risk. The recall specifically impacts Aisys CS2, Avance CS2, and Aestiva/5 MRI anesthesia systems. GE Healthcare's required action is to retrieve the affected devices, with detailed information concerning specific models, specifications, and batches provided in the 'Medical Device Recall Event Report Form'. This measure ensures compliance with regulatory standards and prioritizes patient safety.

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