China NMPA Product Recall - Ultrasonic dental scaler

On November 14, 2019, Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its ultrasonic dental scalers. This action was prompted by an inspection of product GJ19060012, which revealed significant inconsistencies. Specifically, the voltage of the power adapter did not match the input power markings on the main unit, and the product failed to meet its defined technical requirements. The recalled devices are identified under Registration Certificate No. CFDA (Imported) 2014 No. 2551513. The company, which holds a Shanghai Food and Drug Administration Medical Device Registration Certificate No. 2019-280, is taking this corrective measure to address these non-compliance issues. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) in China, which governs medical device safety and quality. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Medmax is required to provide detailed information regarding the affected models, specifications, and batch numbers in a "Medical Device Recall Event Report Form" to ensure comprehensive management of the recall process. This action underscores the company's commitment to product safety and adherence to national medical device standards.