China NMPA Product Recall - Medical angiography X-ray machine

Siemens Healthineers initiated a voluntary Class II recall for its Artis Zeego medical angiography X-ray machines, as reported by the National Medical Products Administration (NMPA) on September 30, 2021. This action addresses a software anomaly discovered during the manufacturer's system testing. The core issue involves the Artis Zeego system's software misinterpreting examination table rotations exceeding 4 degrees. This misinterpretation can cause the 3D image reconstruction display to be rotated by up to 5 degrees relative to the patient, potentially leading to improper system usage. While identified during internal testing, Siemens Healthineers stated that no installed Artis Zeego systems had exhibited this problem at the time of the recall report. The recall, overseen by the NMPA's regulatory framework, mandates the company to address this software defect. Detailed information regarding affected product models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form." This proactive recall highlights Siemens Healthineers' commitment to patient safety and product integrity, ensuring that medical devices function accurately in clinical environments.