China NMPA Product Recall - Cardiovascular X-ray device

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its cardiovascular system angiography X-ray device, as announced by the National Medical Products Administration (NMPA) on October 15, 2020. This action addresses a potential safety concern where the suspended C-arm device might experience unexpected movement during specific operations when the operating handle is used in a particular position. Although described as an "extremely small possibility," this issue could compromise patient safety and device performance. The NMPA, the governing regulatory body in China, oversees this recall to ensure compliance with medical device safety standards. A Class III recall indicates that the product defect has a low probability of causing serious adverse health consequences, but corrective action is still necessary to mitigate potential risks. Shimadzu Enterprise Management (China) Co., Ltd. is responsible for implementing this recall, which involves identifying and addressing all affected units of the cardiovascular system angiography X-ray device. Further details regarding the specific product models, specifications, and batches involved in this recall are provided in an accompanying Medical Device Recall Event Report Form. This proactive measure aims to ensure the continued safety and reliability of medical devices in clinical use.