# China NMPA Product Recall - Anesthesia system

Source: https://www.globalkeysolutions.net/records/china_product_recall/general-medical-equipment-shanghai-co-ltd/cfd5aa05-85c5-4803-8e9c-195ad2668108/
Source feed: China

> China NMPA product recall for Anesthesia system by General Medical Equipment (Shanghai) Co., Ltd. published December 13, 2021. Recall level: Level 2 Recall. On December 13, 2021, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II rec

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Devices (Shanghai) Co., Ltd. voluntarily recalls anesthesia systems.
- Company Name: General Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2021-12-13
- Product Name: Anesthesia system
- Recall Level: Level 2 Recall
- Recall Reason: The issue of a Perseus A500 anesthesia machine detaching from the Dräger Movita suspension system arose due to abnormal user operation in a very rare incident.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: General Medical Equipment (Shanghai) Co., Ltd.
- Summary: On December 13, 2021, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its anesthesia systems. This action, reported by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration, addresses a critical safety concern. The recall stems from a rare incident where a Perseus A500 anesthesia machine detached from a Dräger Movita suspension system during user operation. The core issue identified relates to a potential safety risk arising from improper user operation that led to the unexpected detachment of the medical device from its support system. While characterized as a rare occurrence, the potential for detachment of an anesthesia machine during use necessitates a proactive response to safeguard patient and user safety. Under the regulatory oversight of the NMPA, Dräger Medical Devices (Shanghai) Co., Ltd. is taking the required action of a voluntary recall. This involves identifying and managing all affected anesthesia systems, specifically those referenced under Registration Certificate No.: 国械注进 20143085277. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in the associated Medical Device Recall Event Report Form, indicating a structured approach to address this safety matter.

Company: https://www.globalkeysolutions.net/companies/general-medical-equipment-shanghai-co-ltd/e78bec1e-b5e6-44db-9c62-8b77dec44ed4/