China NMPA Product Recall - Respiratory therapy system; ventilator; Intensive Care Ventilator

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level II recall on September 22, 2021, for specific respiratory therapy systems, ventilators, and Intensive Care Ventilators. This action was reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by findings from global post-market surveillance activities, which identified a restart issue in some ventilator products. The core problem is attributed to an error in the data processing of the activated CO2 measurement module, causing the ventilator to restart unexpectedly. Although a restart is a designed system recovery function, these spontaneous reboots due to the data processing anomaly are unintended. Importantly, Dräger has confirmed that no adverse effects on patient health have been reported in connection with this issue. The company is undertaking proactive steps to address this product performance concern. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form, highlighting a structured approach to managing the situation and upholding patient safety under NMPA's regulatory guidance.