China NMPA Product Recall - Ventilator

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.