China NMPA Product Recall - X-ray angiography system

On June 24, 2019, Siemens Healthineers Ltd. initiated a voluntary Class II recall for several models of its X-ray angiography systems. This action followed a recall notice (2019-140) issued by the Shanghai Food and Drug Administration, operating under the regulatory framework of the National Medical Products Administration (NMPA). The primary issue identified was a manufacturing tolerance fault within the controller power supply of the A100 high-voltage generator. This defect could potentially impede the system's ability to consistently deliver the required voltage to the X-ray tube, particularly when operating at higher voltage thresholds. The recall impacts numerous devices, as indicated by a series of import medical device registration numbers. A Class II recall signifies that the product's use may lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Comprehensive details regarding the specific affected models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form," providing full transparency for stakeholders.