China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class II recall of its medical angiography X-ray machine on January 14, 2019. This action, reported to the National Medical Products Administration (NMPA), addresses two key operational issues. Firstly, the company found that in rare circumstances, equipment malfunction noise could interfere with the synchronous transmission of image data, potentially compromising image quality. Secondly, under specific abnormal operating conditions, performing fluoroscopy immediately after equipment startup and registration inspection could lead to the application restarting. This restart then presented concerns regarding the normal functionality of subsequent fluoroscopy and radiography. The recall demonstrates Shimadzu's adherence to regulatory frameworks for medical device safety in China and aims to mitigate potential risks associated with the identified issues. Detailed information regarding affected product models, specifications, and batches is provided in the accompanying Medical Device Recall Event Report Form.