China NMPA Product Recall - X-ray computed tomography equipment

Siemens Healthcare GmbH, operating under the regulatory framework of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) equipment. This significant action, publicly reported by Siemens Healthineers on June 16, 2022, addresses a critical product integrity concern. The core issue involves a potential data loss problem that has been identified in certain models and batches of their CT devices when operated under specific procedures. The recall specifically targets products associated with Registration Certificate No.: 20213060094. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided within the accompanying "Medical Device Recall Event Report Form" attachment. This proactive measure by Siemens Healthcare GmbH underscores the company's dedication to maintaining high standards of patient safety and product reliability. The NMPA, as the authoritative body responsible for medical device regulation, is overseeing this recall process to ensure that all necessary actions are taken to mitigate potential risks to users and patients. Such voluntary recalls are essential components of regulatory compliance, demonstrating a manufacturer's commitment to promptly addressing and rectifying product deficiencies to protect public health. This recall notification was published by the NMPA on June 17, 2022.