China NMPA Product Recall - Anesthesia machine

Draeger Medical GmbH, in cooperation with its Chinese entity Draeger Medical Equipment (Shanghai) Co., Ltd., initiated a voluntary recall of its anesthesia machines (models Fabius GS Premium and Fabius Tiro) in China. The National Medical Products Administration (NMPA), formerly CFDA, oversaw this action, which was formally reported in November 2013 and published in December 2013. The critical issue identified was a potential power supply failure, posing a significant risk of automatic breathing function failure if the device was moved during operation. This defect affected 153 units imported and sold within China. In response to this safety concern, Draeger Medical GmbH implemented two key corrective actions: issuing safety notices to all affected customers and conducting on-site replacements of the problematic power supplies to rectify the identified hazard and ensure patient safety.