China NMPA Product Recall - Ventilator

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.