China NMPA Product Recall - Medical diagnostic X-ray machine

Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Class III recall in November 2018 for 26 units of their Medical Diagnostic X-ray Machines, specifically model SONTU100-DRF. This action stemmed from an internal audit conducted around that time, which uncovered critical omissions and incomplete information within the product's instruction manual template. The identified issues included insufficient descriptions pertaining to trademarks, the product's intended scope, and its appropriate usage environment. The recall operates under the regulatory guidance of China's National Medical Products Administration (NMPA), aligning with the standards for medical device registration and compliance. The company clarified that these manual discrepancies did not, in fact, negatively affect the product's performance or safety for routine customer use. As a required action, Shenzhen Shentu Medical Imaging Equipment Co., Ltd. is actively informing all affected customers about the issue and detailing how they can obtain the newly revised instruction manuals. It is important to note that this recall focuses solely on updating documentation and does not necessitate the physical return of the X-ray machines, which are confirmed to be safe and operational for continued use.