China NMPA Product Recall - Mobile C-arm digital X-ray system

GE OEC Medical Systems, Inc., through its distributor GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., initiated a voluntary recall of several mobile C-arm digital X-ray systems. This recall, reported to the National Medical Products Administration (NMPA) on December 23, 2016, and publicly announced on January 13, 2017, addresses issues with the workstation power cords. The affected products include specific models of Mobile C-Arm Digital X-ray Systems, Series 9800 X-ray Machines, and Mobile C-Arm X-ray Machines, designed for various diagnostic and interventional procedures. The primary concern is that random failures in the power cord can lead to a loss of image functionality during use, posing a risk of surgical interruption. While no injuries have been reported, this malfunction could potentially necessitate additional medical intervention. It is crucial to note that, due to differences in power cord specifications, the specific affected product batches were not sold or imported into China. In response, the NMPA has requested all provincial Food and Drug Administration bureaus to enhance supervision and management of similar products, emphasizing a commitment to patient safety and product reliability.