China NMPA Product Recall - Mobile C-arm X-ray machine

On March 26, 2019, Siemens Healthineers announced a Class II voluntary recall of its mobile C-arm X-ray machines. This action was reported under the oversight of the National Medical Products Administration (NMPA), with the product also holding a medical device registration certificate from the Shanghai Food and Drug Administration. The primary issue identified was that under high power output conditions and prolonged operation, the X-ray tube in the product could experience rapid wear and tear within the X-ray assembly. This defect has the potential to impact the machine's performance and patient safety during diagnostic procedures. As a required action, Siemens Healthineers initiated this voluntary recall. A Class II recall indicates a situation where a product defect may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Comprehensive details regarding the affected models, specifications, and batch numbers are provided in an attached 'Medical Device Recall Event Report Form', ensuring transparency and guiding necessary actions for customers and regulatory bodies to address the identified product concern.