China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its medical angiography X-ray machines, as reported on October 15, 2020. This action, overseen by the National Medical Products Administration (NMPA) and sourced from the Shanghai Municipal Drug Administration, addresses a potential safety concern. The primary issue involves a very small possibility of unexpected movement in the suspended C-arm device when the operating handle is used for specific operations in a particular position. The affected products are identifiable by Registration Certificate No.: 国食药监械（进）字2009第3302687号, with specific models, specifications, and batches detailed in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product safety and compliance with regulatory expectations under the NMPA framework, ensuring patient and operator safety by addressing potential device malfunctions promptly.