China NMPA Product Recall - Whole-body X-ray computed tomography (CT) system; X-ray computed tomography equipment (Revolution CT, Revolution CT ES, and Revolution Apex systems).

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of specific whole-body X-ray computed tomography (CT) systems and X-ray computed tomography equipment. This action, reported on January 12, 2021, and subsequently published by the National Medical Products Administration (NMPA) on January 14, 2021, addresses a significant product safety concern. The main issue identified by GE Healthcare involves certain Revolution CT, Revolution CT ES, and Apex systems, where sharp edges of exposed scanning bed screws may pose a risk of causing scratches or other related problems. Operating under the regulatory framework of the NMPA, the company is undertaking this recall to mitigate the identified safety hazard. The required action is a voluntary recall, indicating the company's proactive response to address the defect. Customers with affected models, specifications, and batches (identified by registration certificate numbers 20143305741, 20143065741, 20183060452, and 20203060334) are directed to consult the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific products involved and the necessary steps to be taken, ensuring patient and user safety.