China NMPA Product Recall - X-ray equipment for computed tomography

On December 9, 2020, Siemens Healthineers initiated a voluntary Class II recall of its X-ray equipment for computed tomography, under the oversight of the National Medical Products Administration (NMPA). The recall stems from a critical software issue affecting product operation. Specifically, under certain operating sequences, the system may fail to accept potential changes to scanning or reconstruction-related parameters. A very small possibility exists where the graphical user interface incorrectly displays parameters as changed, even though the actual scan executes previously configured parameters. This discrepancy poses a significant concern for diagnostic accuracy and patient safety, as medical professionals might unknowingly proceed with incorrect settings. The affected products include specific models with registration certificate numbers 20183300071, 20183060438, and 20193061896. Detailed information regarding the full scope of affected product models, specifications, and batches is provided in an accompanying Medical Device Recall Event Report Form. This action by Siemens Healthineers is a proactive measure to address the software anomaly and ensure the reliability and safety of their diagnostic imaging equipment.