# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/582da233-0b74-4579-afa9-86e955eb5cab/
Source feed: China

> China NMPA product recall for Ventilator by Air Liquide Medical Systems S.A. published July 05, 2017. Recall level: Level 2. Air Liquide Medical Systems S.A. initiated a Class II voluntary recall for its Monnal T50 ventilator

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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 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. initiated a Class II voluntary recall for its Monnal T50 ventilators, as reported to the National Medical Products Administration (NMPA) on June 19, 2017, and publicly announced on July 5, 2017. The recall addresses 4267 units globally, including 7 specific units in China, all with serial numbers prior to MT50-4540. The primary issues involve a defect in the power board that can lead to an unexpected 5V voltage loss and sudden machine shutdown. Additionally, improper use of the built-in battery by overseas home users resulted in a rapid decrease in effective charge, causing sudden automatic shutdowns when the device relies solely on battery power. In response, Air Liquide Medical Systems S.A. is notifying six affected hospitals to immediately cease use of the identified ventilators and offering backup units. The company is also issuing a comprehensive notification to all hospitals in China using this model, providing recall instructions, user reminders for prompt battery charging, and outlining handling procedures. Furthermore, external alarm devices will be provided to the six directly affected hospitals to alert staff during a ventilator shutdown, with a commitment to implement the manufacturer’s final solution swiftly.

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