# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/5778dd71-7ebc-415b-8e3d-1bffb4c31f33/
Source feed: China

> China NMPA product recall for Ventilator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published October 11, 2017. Recall level: Level 3 Recall. On October 11, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiates voluntary recall of ventilators
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2017-10-11
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: Involves errors in the Chinese labels of the products.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On October 11, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The recall pertains to ventilators, specifically those under Registration No.: CFDA 2014 No. 3542007. The primary reason for this action was an identified error in the Chinese labeling of the affected products. As part of its commitment to product quality and regulatory compliance, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. proactively reported this labeling discrepancy. The Class III recall level signifies that the issue is unlikely to cause adverse health consequences. Detailed information concerning the specific models, specifications, and batch numbers of the recalled ventilators is available in the accompanying "Medical Device Recall Event Report Form." This proactive measure by the company, overseen by the NMPA, aims to ensure that all medical devices meet the necessary labeling standards for the safety and clear understanding of users in the Chinese market. This event highlights the importance of accurate product information and the responsiveness of manufacturers to uphold regulatory requirements.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/