China NMPA Product Recall - Revolution CT

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., on behalf of manufacturer GE Medical Systems, LLC, initiated a voluntary Class II recall for its Revolution CT Whole-Body X-ray Computed Tomography System. This action, reported to the National Medical Products Administration (NMPA) on May 12, 2016, and published July 6, 2016, addresses a critical safety concern. The primary issue identified is the potential for the Revolution CT scanning bed to move unexpectedly during scans of large patients, and for the scanning bed plate to drop during user operation. While no injuries have been reported, this malfunction presents a potential risk of hand injury if a patient's hand is positioned between the bed entry device and the gantry bore. Affected products were distributed across various regions, including the USA, Australia, Canada, and China. To mitigate these risks, GE Healthcare implemented corrective actions, including sending direct email communications to customers to inform them of the issue and provide guidance on safe use. Additionally, the company committed to deploying engineers to customer sites to perform complimentary modifications and corrections on all affected units, ensuring the safety and proper functionality of the Revolution CT systems in compliance with NMPA's regulatory standards.