# China NMPA Product Recall - Anesthesia system

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/d6334929-e290-4ec3-9632-a9a990e486d7/
Source feed: China

> China NMPA product recall for Anesthesia system by Datex-Ohmeda, Inc. published April 21, 2016. Recall level: Level II. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., acting as the responsible unit for m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalls anesthesia systems.
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2016-04-21
- Product Name: Anesthesia system
- Recall Level: Level II
- Recall Reason: GE Healthcare recently learned of a potential safety concern regarding the instantaneous automatic escalation of anesthetic dosage when using 21% oxygen on the Aisys CS2 anesthesia device. This instantaneous escalation could potentially cause hypotension in several vulnerable patients using 21% oxygen (pure air), posing a potential danger. To date, there have been no reports of injuries due to this issue.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., acting as the responsible unit for manufacturer Datex-Ohmeda, Inc., initiated a Class II medical device recall for its Aisys CS2 anesthesia systems. The issue, formally reported on February 24, 2016, concerns a potential instantaneous automatic increase in anesthetic dose when the device is used with 21% oxygen. This malfunction presents a safety risk, as it could lead to hypotension in vulnerable patients, although no injuries have been reported. The recall, overseen by the National Medical Products Administration (NMPA) of China, affects 25 units sold in China out of 30 imported, with a global impact. To address this, GE Healthcare committed to two main corrective actions. They first communicated directly with all customers, detailing the safety concern and providing guidance for safe operation. Secondly, the company dispatched engineers to customer sites to perform necessary, free-of-charge corrections on the identified Aisys CS2 anesthesia systems, ensuring the safe and accurate delivery of anesthesia.

Company: https://www.globalkeysolutions.net/companies/datex-ohmeda-inc/3f7d50b4-53f8-4a07-a7a6-7a3c0147c9e2/