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

Siemens Healthcare GmbH, operating as Siemens Healthineers Ltd., has initiated a voluntary Class II recall of its X-ray equipment for computed tomography. This action, publicly announced by the National Medical Products Administration (NMPA) on December 2, 2021, addresses a critical issue affecting specific models and batches of their products. The primary concern is a potential for reduced image quality when a particular software version is utilized for head scans. This defect could compromise the diagnostic utility of the devices, which are identified by various registration certificate numbers including 20183060438 and 20173301120. In adherence to the NMPA's regulatory guidelines, Siemens Healthcare GmbH is taking this necessary step to ensure product safety and quality. Comprehensive details concerning the affected product models, specifications, and batch information are provided in the official "Medical Device Recall Event Report Form." This ensures that healthcare providers and regulatory bodies have access to all pertinent information to manage the recall effectively, upholding patient safety standards.