China NMPA Product Recall - Patient monitor

GE Healthcare Finland Oy initiated a voluntary recall for specific patient monitors due to a critical software malfunction, as reported to the National Medical Products Administration (NMPA) on September 27, 2017, with an internal company report dated August 8, 2017. The issue involves Patient Data Modules (PDM, software version V2.6) when used with host software version V2.0.7 or earlier on patient monitor models B850, B650, and B450. Under these conditions, the monitors fail to produce essential visual and auditory apnea alarms during an apnea event. Instead, the device incorrectly displays the respiratory rate, potentially delaying critical medical response. While no patient injuries have been reported, this defect poses a significant patient safety risk. The recall, overseen by the NMPA in China through its reporting agent GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., primarily affects products sold in regions such as the European Economic Area and the United States, as the specific recalled products were not distributed within China. The required action is the recall of these affected patient data modules to mitigate potential harm and uphold device reliability.