China NMPA Product Recall - Digital urological examination X-ray system, digital urological X-ray system

Siemens Healthineers initiated a voluntary Level II recall for its Digital Urological Examination X-ray System, as reported by the National Medical Products Administration (NMPA) on March 6, 2019. The recall stems from a manufacturing error in the display support arm. This defect could potentially cause the rotating arm, which secures the display, to detach from the main support arm. The recall impacts products identified under registration certificates CFDA (Imported) 2012 No. 3300030 and CFDA Import Registration No. 20153301187, as well as the Shanghai Food and Drug Administration Medical Device Registration Certificate No. 2019-043. Siemens Healthineers is providing detailed information on specific models, specifications, and batches involved through an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with regulatory standards set by authorities like the NMPA.