China NMPA Product Recall - Medical angiography X-ray machine

On April 13, 2021, Siemens Healthineers Ltd. initiated a voluntary Class II recall for several models of its medical angiography X-ray machines. This action was reported by the Shanghai Municipal Drug Administration, operating under the regulatory oversight of the National Medical Products Administration (NMPA). The recall stems from a critical issue identified in certain Artis systems, specifically relating to improper cleaning practices. This deficiency led to unexpected corrosion on visible belts within the devices, which could potentially compromise their functionality and safety. Siemens Healthineers Ltd. is addressing this manufacturing deviation by recalling specific models, identified by their registration certificate numbers (e.g., 20183301896; 20183301902). Comprehensive details regarding the affected product models, specifications, and batches are available in the