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

On January 13, 2017, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by GE OEC Medical Systems, Inc., the manufacturer of several Mobile C-Arm Digital X-ray Systems, including Series 9800 and OEC 9900 Elite models. The recall stemmed from a critical issue with workstation power cords, which could lead to random failures and a functional loss of images during use. While no injuries were reported, this defect presented a potential risk of surgical interruption, possibly requiring further medical intervention. The NMPA published this information, with GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. acting as the responsible unit in China. Importantly, GE OEC Medical Systems, Inc. confirmed that the affected product batches were not sold in China due to different power cord specifications. Therefore, no direct product retrieval or corrective actions were necessary within the Chinese market. The NMPA’s required action for local authorities was to strengthen supervision and management of similar products within their jurisdictions. The recall primarily impacted regions such as the USA and Canada.