# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/fd4a641b-9e02-4665-bcac-70841d7c920b/
Source feed: China

> China NMPA product recall for Ventilator by Air Liquide Medical Systems S.A. published July 10, 2017. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued a notification on July 10, 2017, detailin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Air Liquide Medical Systems S.A. initiates ventilator recall
- Company Name: Air Liquide Medical Systems S.A.
- Publication Date: 2017-07-10
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: A defective power board may cause an unexpected loss of 5V voltage, resulting in sudden shutdown of the machine; improper use of the built-in battery by overseas home users may cause a rapid decrease in the battery's effective charge, leading to 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: The National Medical Products Administration (NMPA) issued a notification on July 10, 2017, detailing a Class II voluntary recall initiated by Air Liquide Medical Systems S.A. This recall pertains to their ventilators, specifically models with serial numbers prior to MT50-4540, sold under Registration Certificate No.: CFDA (Imported) 2014 No. 3540539. The recall addresses two primary concerns. Firstly, a defect in the power board can lead to an unexpected loss of 5V voltage, resulting in the ventilator shutting down abruptly. Secondly, the manufacturer identified that improper use of the built-in battery by overseas home users could cause a significant and sudden decrease in effective battery charge, leading to an automatic shutdown when the device operates solely on battery power. Air Liquide Medical Supplies (Beijing) Co., Ltd. reported these findings to the NMPA, leading to this corrective action. A Class II recall indicates a situation where the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Details on affected models, specifications, and batches are available in the 'Medical Device Recall Form.'

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