China NMPA Product Recall - X-ray computed tomography equipment

On October 21, 2021, the National Medical Products Administration (NMPA) reported that Shanghai Siemens Medical Devices Co., Ltd. initiated a voluntary recall of specific batches of its X-ray Computed Tomography (CT) equipment. The recall, classified as Level III, addresses a critical manufacturing defect involving the patient examination table. The core issue stems from the possibility of missing screws and washers during the assembly process of these tables. This omission could compromise the integrity of the examination table's safety bolts, preventing them from being tightened securely and potentially creating a safety hazard for patients during use. In response, Shanghai Siemens Medical Devices Co., Ltd. has not only launched this recall for equipment identified under Registration Certificate Nos.: 20173301355; 20183060594; 20203060778 but has also commenced on-site corrective actions to rectify the manufacturing oversight directly. This proactive measure aims to ensure the safety and reliability of their medical devices in accordance with NMPA's regulatory expectations, mitigating potential risks associated with the affected CT equipment.