# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/weinmann-emergency-medical-technology-gmbh-cokg/5fc6aa4d-2431-4b02-a271-71e0a8477e1b/
Source feed: China

> China NMPA product recall for Ventilator by WEINMANN Emergency Medical Technology GmbH + Co.KG published October 07, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) in China has published a notice concerning a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: WEINMANN Emergency Medical Technology GmbH + Co.KG initiates voluntary recall of ventilators.
- Company Name: WEINMANN Emergency Medical Technology GmbH + Co.KG
- Publication Date: 2023-10-07
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: In rare cases, the equipment self-test, as part of the equipment startup process, may cause equipment malfunction, rendering the equipment unusable immediately.
- Discovering Company: Viman (Shanghai) Medical Device Trading Co., Ltd.
- Manufacturing Company: WEINMANN Emergency Medical Technology GmbH + Co.KG
- Summary: The National Medical Products Administration (NMPA) in China has published a notice concerning a voluntary recall initiated by WEINMANN Emergency Medical Technology GmbH + Co.KG. The recall, reported by WEINMANN (Shanghai) Medical Device Trading Co., Ltd., involves specific Ventilator models (National Medical Device Registration Certificate 20153081989). The main issue is a potential malfunction during the device's self-test at startup. In rare cases, this self-test can fail, immediately rendering the ventilator unusable, which presents a critical safety risk for patients dependent on respiratory support. This voluntary recall is a proactive measure by WEINMANN Emergency Medical Technology GmbH + Co.KG under the regulatory framework of the NMPA to address the identified product defect. The recall was announced on October 7, 2023. Detailed information on the affected product models, specifications, and batch numbers is provided in an attached "Medical Device Recall Event Report Form." There are no inspection dates mentioned in this recall notification, as it appears to be a company-initiated voluntary action rather than a direct consequence of a regulatory inspection. The required action is the removal of the affected devices from circulation to ensure patient safety.

Company: https://www.globalkeysolutions.net/companies/weinmann-emergency-medical-technology-gmbh-cokg/2f143c2c-6365-4856-8bdd-ba14924824da/