China NMPA Product Recall - The Patient Data Module (PDM) in a patient monitor.

GE Healthcare Finland Oy has initiated a voluntary global recall of its Patient Data Modules (PDMs) integrated into patient monitors, specifically the B650 model. This recall was formally reported to China's National Medical Products Administration (NMPA) by General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. The primary concern is that liquid ingress through the panel seals could reach electrical contacts on the circuit board, potentially causing the module to overheat. This overheating may result in smoke, discoloration, and thermal injuries to patients or caregivers, posing a significant safety risk. Although the recall is global, GE Healthcare confirmed that none of the affected batches of these Patient Data Modules were sold or distributed within China. Therefore, no direct product retrieval or specific corrective actions are required for the Chinese market. However, the NMPA has proactively requested that provincial and municipal food and drug administrations intensify their oversight and management of similar medical devices to maintain rigorous safety standards. The recall documentation was published on December 12, 2013.