China NMPA Product Recall - Interventional imaging systems equipped with the recall-affected gantry motion control board (MCB)

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level 3 recall on June 3, 2015, under the oversight of the National Medical Products Administration (NMPA) of China. The recall addresses a critical issue affecting several interventional imaging systems, including the INNOVA 3100, INNOVA 3100-IQ, Innova IGS 530, and Innova IGS 630 models. The primary concern stems from a failure of the gantry motion control board (MCB), which can cause the gantry to stop moving. While systems can be reset and manual controls remain functional, and no personnel injuries have been reported, this malfunction has the potential to prolong interventional procedures and impair diagnostic and image guidance performance. In response, GE Healthcare implemented two key corrective actions. The company communicated directly with affected customers via email, providing essential guidance for safe system operation. Additionally, GE Healthcare dispatched engineers to customer sites to perform necessary free corrections on all impacted products. This recall extends to multiple global regions, including China, the United States, the European Economic Area, and Canada.