# China NMPA Product Recall - Anesthesia machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-critical-care-ab/89444899-8482-48ad-ac14-318ce736532a/
Source feed: China

> China NMPA product recall for Anesthesia machine by Maquet Critical Care AB published January 31, 2023. Recall level: Level 2 Recall. MAQUET CRITICAL CARE AB, supported by MAQUET (Shanghai) Medical Equipment Co., Ltd., initiated a vol

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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: 2023-01-31
- Product Name: Anesthesia machine
- Recall Level: Level 2 Recall
- Recall Reason: This involves specific models and batches of products that have ventilation issues.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maquet Critical Care AB
- Summary: MAQUET CRITICAL CARE AB, supported by MAQUET (Shanghai) Medical Equipment Co., Ltd., initiated a voluntary Class II recall of specific anesthesia machine models and batches, as announced by the National Medical Products Administration (NMPA) on January 31, 2023. The recall stems from a critical ventilation problem identified in the affected devices, which could compromise patient safety. This issue prompted the manufacturer to take swift corrective action under the NMPA's regulatory framework. The recall specifically impacts anesthesia machines registered under Certificate Nos.: 20163082966 and 20223080583. Although no specific inspection dates were provided in the document, the recall itself represents a regulatory response to a detected product deficiency. MAQUET CRITICAL CARE AB is addressing the ventilation issue, and further details, including affected models, specifications, and batch numbers, are available in the "Medical Device Recall List" and the "Medical Device Recall Event Report Form" for stakeholders and healthcare professionals.

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