China NMPA Product Recall - Positron emission tomography (PET) and computed tomography (CT) imaging systems, LightSpeed CT system, whole-body X-ray CT system, computed tomography imaging system

On July 22, 2015, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., in collaboration with GE Medical Systems, initiated a voluntary recall of several imaging products, including Positron Emission Tomography and Computed Tomography (CT) systems. This action was reported to the National Medical Products Administration (NMPA) in China, referencing relevant registration numbers. The recall was prompted by the discovery of an incorrect installation torque value specified for the power supply during replacement procedures for the rotating part of the scanner gantry. This critical error could lead to the power supply's fixing threads becoming overloaded, potentially loosening during gantry rotation, and in extreme cases, causing the power supply to eject outwards, posing a significant risk of serious personal injury. While no on-site incidents or injuries related to this specific defect have been reported, GE Healthcare is implementing proactive measures. The required corrective actions include informing affected customers via email with guidance on safe use and dispatching engineers to perform complimentary, on-site corrections for all impacted devices to ensure patient safety and product integrity.