China NMPA Product Recall - Medical diagnostic X-ray machine

Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Class III recall for 26 units of its SONTU100-DRF medical diagnostic X-ray machines in China. This action, reported on November 1, 2018, and publicized by the National Medical Products Administration (NMPA) on November 17, 2018, resulted from an internal audit. The audit revealed that the product's instruction manual template contained incomplete information regarding trademarks, product scope, and usage environment. While the identified issue did not impact the normal operation or performance of the X-ray machines, the company proceeded with the recall to address non-compliance with relevant medical device regulatory documentation standards. The required action involves notifying all affected customers through follow-up communications to provide them with updated instruction manuals. There is no physical product recall as the devices remain fully functional and in normal working order, focusing solely on correcting the documentation deficiency.