China NMPA Product Recall - Mobile C-arm X-ray machine

Beijing GE Healthcare Co., Ltd. initiated a voluntary Class II recall of its mobile C-arm X-ray machines, specifically models Brivo OEC 715 and Brivo OEC 785. This action was publicly reported by the National Medical Products Administration (NMPA) on September 29, 2016, following the company's internal report on September 22, 2016. The core issue involves a potential malfunction in the circuit board controlling the C-arm's movement, which could lead to unexpected motion. This uncontrolled movement poses a risk of soft tissue injury if it occurs during surgical procedures or results in collisions with other medical equipment. Although no injuries have been reported to date, the recall encompasses devices distributed in China, the USA, and the European Economic Area/Switzerland. Under the NMPA's regulatory framework, Beijing GE Healthcare is taking corrective actions, including directly notifying customers via email about the issue and providing essential guidance on the safe operation of the affected products. This demonstrates a proactive approach to ensure patient safety and compliance with medical device standards.