China NMPA Product Recall - Medical angiography X-ray machine

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., on behalf of manufacturer GE MEDICAL SYSTEMS SCS, initiated a voluntary Class II recall for its Medical Angiography X-ray Machines, specifically the Discovery IGS 730 model. This recall was officially reported on December 10, 2014, and published by the National Medical Products Administration (NMPA) on December 22, 2014. The primary issue involves a positioning control interface defect that can lead to uncontrolled movement or rotation of the bed/gantry. When the smart controller handle is pushed to its maximum limit, the system may move in the reverse direction. This unexpected movement poses a significant safety risk, potentially causing the bed or C-arm to collide with other medical equipment, patients, or nearby personnel, leading to injury. In response to this critical safety concern, GE Healthcare outlined specific corrective actions. Customers were immediately notified via email regarding the operational hazard. While awaiting on-site intervention, users are advised to continue using the affected X-ray machines but cautioned against pushing the smart controller handle to its maximum position. Furthermore, GE Healthcare committed to deploying engineers to customer locations to implement the necessary corrections on all affected units to mitigate the identified risk and restore safe functionality. This recall impacts units in various regions, including China, the USA, and the European Economic Area.