China NMPA Product Recall - Ventilator

Air Liquide Medical Systems S.A. initiated a Class II voluntary recall of its Monnal T50 Ventilators, as reported to the National Medical Products Administration (NMPA) on June 19, 2017. The recall was prompted by two significant issues affecting the device. Firstly, a defect in the power board of ventilators with serial numbers prior to MT50-4540 could lead to an unexpected loss of 5V voltage, causing the machine to suddenly shut down. Secondly, improper use of the built-in battery by overseas home users resulted in a rapid depletion of effective battery charge, also leading to sudden automatic shutdown when operating solely on battery power. The recall impacts 4267 units globally, with 7 identified units in China. Under the NMPA's regulatory framework (CFDA (Imported) 2014 No. 3540539), Air Liquide Medical Supplies (Beijing) Co., Ltd., as the agent, implemented several required actions. These included immediately notifying six affected hospitals to cease using the identified ventilators and offering backup units. Furthermore, a broader notification was issued to all hospitals in China using the Monnal T50, detailing corrective actions, user reminders regarding battery management, and handling procedures. To enhance safety, external alarm devices were provided to the affected hospitals to alert users during unexpected shutdowns. The company committed to implementing the manufacturer's final resolution for the affected hospitals promptly upon its release.