China NMPA Product Recall - Ventilator/Respiratory Therapy System

The National Medical Products Administration (NMPA) announced a Level I voluntary recall by Dräger Medical Devices (Shanghai) Co., Ltd. for its ventilators and respiratory therapy systems. This action, published on March 17, 2017, addresses a persistent battery defect within the PS500 auxiliary power supply.

Dräger Medical Devices (Shanghai) Co., Ltd. initially initiated recall measures for the problematic PS500 auxiliary power supply in February 2016. However, despite these prior efforts, the company determined that the battery defect issue still required further improvement. Consequently, the company decided to undertake a more comprehensive recall.

Under the regulatory oversight of the NMPA, Dräger Medical Devices (Shanghai) Co., Ltd. is now implementing this Level I recall, indicating a high potential for serious health consequences. The specific models, specifications, and batches of the affected products are detailed in the accompanying "Medical Device Recall Event Report Form." This ongoing voluntary recall underscores the company's commitment to resolving the identified safety concern and ensuring the reliability of its medical devices, in compliance with NMPA standards.