China NMPA Product Recall - Dental X-ray machine

Qingdao Haiqing Electronic Medical Instruments Co., Ltd. initiated a voluntary Level III recall of its dental X-ray machines, as announced on September 30, 2020. The recall was prompted by a finding that the input power of these devices did not conform to the product's technical requirements, as identified against the National Medical Products Administration (NMPA) catalog. The specific registration certificate number for the affected machines is Lu Xie Zhu Zhun 20172300805. This issue indicates a deviation from established technical standards for medical devices within China. The regulatory oversight for this recall involves the National Medical Products Administration (NMPA) and the Shandong Provincial Drug Administration, which hosted the original announcement. As a required action, Qingdao Haiqing Electronic Medical Instruments Co., Ltd. decided to voluntarily recall the implicated batches of products. Further details regarding the models, specifications, and specific batches subject to the recall are available in the "Medical Device Recall Event Report Form," specifically referenced as the Qingdao Haiqing Dental X-ray Machine Recall Report.