# China NMPA Product Recall - Anesthesia system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-drager-medical-instruments-co-ltd/d5037804-1239-4805-a85a-f2f664d843c8/
Source feed: China

> China NMPA product recall for Anesthesia system by Shanghai Drager Medical Instruments Co., Ltd. published December 04, 2013. Recall level: . Shanghai Dräger Medical Devices Co., Ltd. initiated a voluntary recall of its anesthesia systems (NM

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Drager Medical Devices Co., Ltd. is recalling its anesthesia systems.
- Company Name: Shanghai Drager Medical Instruments Co., Ltd.
- Publication Date: 2013-12-04
- Product Name: Anesthesia system
- Recall Reason: Potential power supply failure poses a risk that the automatic breathing function may fail when the equipment is moved.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Shanghai Drager Medical Instruments Co., Ltd.
- Summary: Shanghai Dräger Medical Devices Co., Ltd. initiated a voluntary recall of its anesthesia systems (NMPA Medical Device Approval No. 20123541755), specifically the Fabius Plus model, affecting 286 units in China. The recall, reported on November 4, 2013, and published on December 4, 2013, was prompted by a critical safety concern: a potential power supply failure that could lead to the automatic breathing function failing when the equipment is moved. This issue posed a significant risk to patient safety, as the systems are designed for inhalation anesthesia and mechanical ventilation in adults, children, and newborns during surgery. Under the oversight of the National Medical Products Administration (NMPA), the company implemented corrective actions to address this serious defect. These actions included issuing safety notices directly to affected customers to inform them of the hazard. Furthermore, Shanghai Dräger committed to on-site replacement of the faulty power supply units in all identified anesthesia systems. The NMPA also instructed provincial food and drug administrations to enhance their supervision and management of these medical devices to ensure patient safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/shanghai-drager-medical-instruments-co-ltd/42202b8f-b6a4-4daf-a10c-c01a3a96fd63/