China NMPA Product Recall - Medical diagnostic X-ray machine

Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Level III recall for 26 units of its SONTU100-DRF Medical Diagnostic X-ray Machines. This action, reported on November 1, 2018, and publicly announced on November 26, 2018, was overseen by China's National Medical Products Administration (NMPA). The recall stemmed from a recent internal audit that revealed incomplete information within the product's instruction manual template. Specifically, the manuals contained insufficient descriptions regarding product trademarks, its intended scope of application, and the usage environment. Although this documentation issue constituted non-compliance with regulatory requirements, the company confirmed that it did not affect the product's performance or safety for customer use.

As a corrective measure, Shenzhen Shentu Medical Imaging Equipment Co., Ltd. is notifying all affected customers and providing them with a revised and updated instruction manual. It is crucial to note that this recall pertains solely to product documentation; the physical X-ray machines themselves are not being retrieved and remain in normal operation, ensuring continued patient care and clinical utility.