China NMPA Product Recall - Cone-beam computed tomography (CBCT) system for oral and maxillofacial region (Product Model PP3-1)

KaVo Shengbang (Shanghai) Dental Medical Devices Co., Ltd. initiated a voluntary Level III recall of its oral and maxillofacial cone-beam computed tomography (PCT) devices. The decision, publicly announced on February 15, 2019, stemmed from an identified labeling error. Specifically, three units of the PP3-1 model, shipped to China in January 2019, contained incorrect product model information on their English labels. This recall activity falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The company's immediate action involves the recall of the affected devices (Registration Certificate No.: 20183060305), with detailed product information available in the accompanying Medical Device Recall Event Report Form. This measure ensures compliance with regulatory standards and addresses the identified labeling discrepancy.