China NMPA Product Recall - Ultrasonic dental scaler

On September 16, 2020, EMS Electronic Medical Systems Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its ultrasonic dental scalers. This action was taken in response to a labeling error discovered on the product nameplate. Specifically, the registration certificate number was incorrectly printed as 国械注进20152553228, when the correct identifier should be 国械注进20162553228. This discrepancy, stemming from a batch number error, represents a documentation and labeling issue rather than a functional defect of the device itself. The recall operates under the regulatory oversight of the National Medical Products Administration (NMPA), China's authority responsible for medical device compliance. A Class III recall typically signifies a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences. EMS Electronic Medical Systems Trading (Shanghai) Co., Ltd. is required to address this non-compliance by removing the affected products from distribution. Further specific details regarding the models, specifications, and batches impacted by this recall are provided in the accompanying "Medical Device Recall Event Report Form," which serves as the official documentation of the event. The company's proactive measure ensures accurate product identification and adherence to regulatory standards for medical device labeling.