China NMPA Product Recall - Ventilator

Air Liquide Medical Systems S.A., in cooperation with its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class III recall of its MONNAL T75 ventilators, as regulated by the National Medical Products Administration (NMPA). This recall, affecting 6,138 units globally, stems from a software malfunction identified in the device. The issue occurs when physicians utilize pressure support ventilation modes (PSV, PSV-NIV, or PS-PRO) and set the pressure support to 2 cmH2O. Under this specific condition, the ventilator prevents users from increasing the PEEP (Positive End-Expiratory Pressure) setting, a limitation that persists even after switching ventilation modes. This inability to properly adjust PEEP carries a risk of inadequate patient ventilation. However, the malfunction's frequency is limited as the default pressure support setting is 10 cmH2O, and no domestic complaints or adverse events have been reported. Corrective actions involve sending safety information notices to all users of the affected MONNAL T75 ventilators and performing necessary software upgrades on all impacted devices, without requiring equipment return.