China NMPA Product Recall - Cone-beam computed tomography (CBCT) equipment for oral and maxillofacial region

KaVo Shengbang (Shanghai) Dental Medical Devices Co., Ltd. initiated a voluntary Level III recall for three units of its Cone-Beam Computed Tomography (CBCT) equipment, specifically designed for oral and maxillofacial regions (Model P). This recall, reported to the National Medical Products Administration (NMPA) on February 20, 2019, arose from the manufacturer's discovery in January 2019 that these particular devices, shipped during the same month, featured incorrect model information on their labels. The affected products are identified by their registration certificate number: "国械注进20183060305". The primary issue involves a labeling error, which, while not immediately posing a direct health risk, requires correction to maintain regulatory compliance and ensure product traceability. The company's proactive decision to undertake a Level III recall indicates that the discrepancy is unlikely to cause adverse health consequences but warrants corrective action. This measure ensures that product information accurately reflects the device specifications. Further details regarding the affected models, specifications, and batch numbers are provided in an accompanying "Medical Device Recall Event Report Form." This action highlights KaVo Shengbang's commitment to upholding product quality and regulatory standards under the NMPA's framework.