China NMPA Product Recall - Medical angiography X-ray machine; X-ray angiography system

Siemens Healthineers Ltd. initiated a voluntary Class II recall for several models of its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on June 24, 2019. This proactive action addresses a potential manufacturing issue involving the screws connecting the pivot bearing to the ceiling bracket on the Display Mount Extension (DCS). There is a very small possibility that these screws could loosen or break, with the frequency of this occurrence being dependent on how often the hanger is used. This recall pertains to specific medical angiography X-ray systems, identified by various National Medical Device Registration Certificates. Siemens Healthineers Ltd. is voluntarily recalling these products to ensure patient safety and device integrity. Detailed information concerning the affected models, specifications, and batch numbers is available in an accompanying "Medical Device Recall Event Report Form."