# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/659d3d7e-a8aa-421e-8f9a-2eabafb51d60/
Source feed: China

> China NMPA product recall for Ventilator by Air Liquide Medical Systems S.A. published July 05, 2017. Recall level: Level 2 Recall. Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd.

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Air Liquide Medical Systems S.A. initiates voluntary recall of ventilators
- Company Name: Air Liquide Medical Systems S.A.
- Publication Date: 2017-07-05
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: 1. The manufacturer discovered a defect in the power board of ventilators with serial numbers prior to MT50-4540, which could cause an unexpected loss of 5V voltage, resulting in sudden automatic shutdown of the machine.
2. The manufacturer discovered that improper use of the built-in battery by overseas home users has caused a sharp decrease in the effective battery charge, resulting in sudden automatic shutdown of the machine (when using only the built-in battery).
- Discovering Company: Air Liquide Medical Supplies (Beijing) Co., Ltd.
- Manufacturing Company: Air Liquide Medical Systems S.A.
- Summary: Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class II recall for its Monnal T50 ventilators, reported to the National Medical Products Administration (NMPA) on June 19, 2017. There were no NMPA inspection dates listed, as this was a company-initiated action. The recall addresses two critical issues: a manufacturing defect in the power board of ventilators with serial numbers prior to MT50-4540, which may lead to an unexpected loss of 5V voltage causing sudden device shutdown; and improper use of the built-in battery by overseas home users, resulting in rapid charge depletion and unexpected shutdowns when operating on battery power only.

The recall impacts 4267 units globally, with 7 specific units identified in China. Under the NMPA's regulatory framework (Registration No.: CFDA (Imported) 2014 No. 3540539), Air Liquide is taking several actions. These include directing 6 affected hospitals in China to immediately cease using the identified ventilators and offering backup units. The company is also issuing a broader notification to all hospitals using this model, emphasizing corrective measures, user vigilance regarding battery levels, and proper charging protocols. External alarm devices will be provided to the 6 affected hospitals to alert users during a sudden shutdown, with the manufacturer's final solution to be implemented promptly.

Company: https://www.globalkeysolutions.net/companies/air-liquide-medical-systems-sa/cc2d56e7-705b-4102-85bb-ace16710dee2/