China NMPA Product Recall - Digital dental X-ray tomography equipment

Hefei Meiya Optoelectronic Technology Co., Ltd. initiated a voluntary Class III recall for its "Digital Tomometry Equipment for Dental X-rays," identified under CFDA Approval No. 20143300400(Revised). The National Medical Products Administration (NMPA) and Anhui Provincial Drug Administration Website announced this recall on June 12, 2019. The primary issue leading to the recall was the unintended use of a nameplate belonging to a prototype device still under development. This labeling discrepancy affects specific models, specifications, and batch numbers, with detailed information available in the company's Medical Device Recall Event Report Form. As a required action, the company is systematically withdrawing the affected products from the market to correct the non-compliance related to product identification. The Class III designation signifies that the product defect is unlikely to cause adverse health consequences, yet the company must identify and retrieve all impacted units to rectify the labeling error, ensuring regulatory standards for medical device accuracy and proper identification are met.