China NMPA Product Recall - Ventilator

Air Liquide Medical Systems S.A., in conjunction with its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class II recall of its ventilators (CFDA (Imported) No. 20143530589), as reported to the National Medical Products Administration (NMPA) on June 19, 2017. The recall addresses two critical issues. Firstly, a defect in the power board of ventilators with serial numbers preceding MT50-04540 could lead to an unexpected 5V voltage loss, causing sudden machine shutdown. Secondly, improper use of the built-in battery by some home users was found to result in a rapid discharge and abrupt automatic shutdown when the device relies solely on battery power. The recall affects 4267 units globally, with 7 specific units identified in China. In response, Air Liquide has mandated that 6 identified Chinese hospitals immediately cease using the affected ventilators, offering replacements as needed. Furthermore, all hospitals using this ventilator model in China are being reminded to diligently monitor battery levels and ensure timely charging. The company is also providing external alarm devices to the affected hospitals, designed to activate upon unexpected shutdown, alerting users to intervene. Air Liquide will implement a permanent solution for the affected hospitals once it is released by the manufacturer.