# China NMPA Product Recall - Anesthesia System

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-critical-care-ab/2a7e1d5e-ce38-4929-8f00-77f3b8f26215/
Source feed: China

> China NMPA product recall for Anesthesia System by Maquet Critical Care AB published September 18, 2024. Recall level: Level 2 Recall. On September 18, 2024, the National Medical Products Administration (NMPA) reported a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MAQUET CRITICAL CARE AB has initiated a voluntary recall of anesthesia machines.
- Company Name: Maquet Critical Care AB
- Publication Date: 2024-09-18
- Product Name: Anesthesia System
- Recall Level: Level 2 Recall
- Recall Reason: The two gaskets on the back cover of the anesthesia machine were misplaced.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maquet Critical Care AB
- Summary: On September 18, 2024, the National Medical Products Administration (NMPA) reported a voluntary Class II recall initiated by MAQUET CRITICAL CARE AB. The recall pertains to their Anesthesia System anesthesia machines (National Medical Device Registration Certificate 20223080583). This action stems from an internal investigation by the manufacturer, which identified a manufacturing defect involving the improper placement of two gaskets on the rear cover of the anesthesia machines. This issue prompted the company to take corrective action to ensure product safety and performance. MAQUET (Shanghai) Medical Equipment Co., Ltd., served as the reporting entity for this recall within China. Importantly, the NMPA document confirms that the specific products involved in this recall were not imported into China. Consequently, while the recall is a global initiative by the manufacturer to address the identified defect, it carries no direct impact or required actions for devices within the Chinese market. The Class II classification indicates that the identified issue could potentially lead to temporary or medically reversible adverse health consequences, though the probability of serious adverse effects is considered remote. This proactive measure by MAQUET CRITICAL CARE AB, overseen by the NMPA, underscores their commitment to product quality and patient safety standards. Further details on specific models and batches are available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/maquet-critical-care-ab/aa5a1d63-4746-4f71-97ad-6b24c8cc7ad5/