# China NMPA Product Recall - Anesthesia machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/maque-care-ab/1ec2ba4a-8165-4c39-ab76-81165e41dd65/
Source feed: China

> China NMPA product recall for Anesthesia machine by MAQUE CARE AB published January 31, 2023. Recall level: Level 3 Recall. MAQUET CRITICAL CARE AB, a medical equipment manufacturer, has initiated a voluntary Level III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MAQUET CRITICAL CARE AB is voluntarily recalling anesthesia machines.
- Company Name: MAQUE CARE AB
- Publication Date: 2023-01-31
- Product Name: Anesthesia machine
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with battery sulfation triggering technology alarms.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: MAQUE CARE AB
- Summary: MAQUET CRITICAL CARE AB, a medical equipment manufacturer, has initiated a voluntary Level III recall for specific anesthesia machines. This action, publicly reported by MAQUET (Shanghai) Medical Equipment Co., Ltd. on January 31, 2023, addresses a critical technical issue: battery sulfation that triggers alarms in certain models and batches of these essential medical devices. The recall is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA), reflecting China's framework for ensuring medical product safety and quality. The main concern revolves around the potential for these technical alarms to compromise the consistent and reliable performance of anesthesia machines, which are vital for patient care during medical procedures. As a required action, the company is actively retrieving the affected devices from the market to mitigate any risks. While specific inspection dates are not provided in this announcement, the voluntary recall signifies a commitment to resolving the identified product deficiency. Comprehensive details, including the precise models, specifications, and batch numbers involved, are documented in the accompanying "Medical Device Recall Event Report Form," enabling healthcare providers to identify and return affected units. This measure underscores the importance of maintaining high standards for medical device functionality and patient safety.

Company: https://www.globalkeysolutions.net/companies/maque-care-ab/613b9e2a-1e6b-4c0d-9a8d-b1660a760147/