China NMPA Product Recall - Ventilator

Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class II recall for its Monnal T50 ventilators, reported to the National Medical Products Administration (NMPA) on June 19, 2017. There were no NMPA inspection dates listed, as this was a company-initiated action. The recall addresses two critical issues: a manufacturing defect in the power board of ventilators with serial numbers prior to MT50-4540, which may lead to an unexpected loss of 5V voltage causing sudden device shutdown; and improper use of the built-in battery by overseas home users, resulting in rapid charge depletion and unexpected shutdowns when operating on battery power only.

The recall impacts 4267 units globally, with 7 specific units identified in China. Under the NMPA's regulatory framework (Registration No.: CFDA (Imported) 2014 No. 3540539), Air Liquide is taking several actions. These include directing 6 affected hospitals in China to immediately cease using the identified ventilators and offering backup units. The company is also issuing a broader notification to all hospitals using this model, emphasizing corrective measures, user vigilance regarding battery levels, and proper charging protocols. External alarm devices will be provided to the 6 affected hospitals to alert users during a sudden shutdown, with the manufacturer's final solution to be implemented promptly.