# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/18c86013-ad71-4e5c-be2d-056b3611386f
Source feed: China

> China NMPA product recall for Ventilator by Air Liquide Medical Systems S.A. published July 19, 2017. Recall level: Level 2 Recall. In July 2017, Air Liquide Medical Systems S.A., via its subsidiary Air Liquide Medical Supplies (Bei

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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: 2017-07-19
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The ventilator's power board has a defect, which may cause an unexpected loss of 5V voltage, leading to the machine suddenly shutting down; improper use of the built-in battery by overseas home users may cause a sharp decrease in the battery's effective charge, resulting in the machine suddenly shutting down automatically.
- Discovering Company: Air Liquide Medical Supplies (Beijing) Co., Ltd.
- Manufacturing Company: Air Liquide Medical Systems S.A.
- Summary: In July 2017, Air Liquide Medical Systems S.A., via its subsidiary Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class II recall of specific ventilators within China. This action was overseen by the National Medical Products Administration (NMPA).

The recall stemmed from two critical safety issues. Firstly, a manufacturing defect was identified in the power boards of ventilators with serial numbers preceding MT50-4540. This flaw could lead to an unexpected loss of 5V voltage, resulting in the device suddenly shutting down during use. Secondly, the manufacturer discovered that improper handling of the built-in battery by overseas home users could cause a sharp and rapid decrease in the battery's effective charge, leading to an abrupt automatic shutdown when the device was operating solely on battery power.

The affected products are identifiable by Registration Certificate No.: CFDA (Imported) 2014 No. 3540539. Air Liquide Medical Systems S.A. is undertaking these proactive measures to mitigate potential risks to patient safety and ensure product reliability. Comprehensive details concerning the specific models, specifications, and batches of the recalled products are available in the accompanying "Medical Device Recall Form" attachment.

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