# China NMPA Product Recall - Anesthesia system

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/ecfb47a0-3ec0-42ad-8a6b-2a61c5bc2915/
Source feed: China

> China NMPA product recall for Anesthesia system by Datex-Ohmeda, Inc. published December 29, 2016. Recall level: . GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary recall of updat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. voluntarily recalls updated anesthesia systems.
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2016-12-29
- Product Name: Anesthesia system
- Recall Reason: GE Healthcare has noted a potential safety issue with certain Avance CS2 anesthesia devices: forcibly closing the lower storage drawer (see PIC01 below) with the optional insert tray may cause the device to malfunction. When malfunctioning, the following may occur: • Automatic activation of auxiliary oxygen flow within seconds; • High-level alarm prompts and audible alerts; • Instructions to set oxygen flow and initiate manual ventilation; • Continued delivery of anesthetic drugs at the currently set concentration. No injuries have been reported related to this issue. Once the user removes the insert tray, the potential risk is eliminated.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary recall of updated Avance CS2 anesthesia systems, with initial reports submitted on October 26, 2016, and an updated report on November 21, 2016. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) and was reported to the Shanghai Food and Drug Administration. The core issue involves a potential malfunction when the lower storage drawer, fitted with a specific insert tray (PIC01-1009-3260-000), is forcibly closed. Such a malfunction can trigger automatic auxiliary oxygen flow, high-level alarms, audible warnings, and instructions for manual ventilation, while still delivering anesthetic drugs at the set concentration. Despite these potential risks, no patient injuries have been reported. Initially, the company notified users of 1163 products, but subsequent precise identification confirmed only four units sold in China were actually affected. As a corrective action, GE Healthcare will issue customer letters detailing the issue and providing guidance on how to identify and remove the problematic insert tray. Users can perform this removal themselves, which will effectively eliminate the identified safety risk, ensuring the device's safe operation.

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