China NMPA Product Recall - Cardiovascular imaging system

Shimadzu Enterprise Management (China) Co., Ltd. has initiated a voluntary Class III recall for its cardiovascular angiography system. This action was announced by the National Medical Products Administration (NMPA) on October 15, 2020, through the Shanghai Municipal Drug Administration website. The recall addresses a critical safety concern where, under specific operational conditions, the suspended C-arm of the device may exhibit unexpected movement. This issue, though occurring in a very small possibility, necessitates immediate corrective measures to ensure patient and user safety. The company is proactively recalling units associated with Registration Certificate No.: 国食药监械（进）字2005第3300009号（更）. This recall falls under the regulatory oversight of the NMPA, which governs medical device safety in China. Detailed information on the specific models, specifications, and batches affected by this recall is available in the accompanying Medical Device Recall Event Report Form. Shimadzu's voluntary action underscores its commitment to product quality and adherence to established medical device regulations.