# China NMPA Product Recall - Ultrasonic dental scaler

Source: https://www.globalkeysolutions.net/records/china_product_recall/medmax-electronic-medical-systems-trading-shanghai-co-ltd/51c29601-ace0-4149-ac71-55052b653b4d
Source feed: China

> China NMPA product recall for Ultrasonic dental scaler by Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd. published September 16, 2020. Recall level: Level 3 Recall. On September 16, 2020, EMS Electronic Medical Systems Trading (Shanghai) Co., Ltd. initiated a volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd. is voluntarily recalling ultrasonic dental scalers.
- Company Name: Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-09-16
- Product Name: Ultrasonic dental scaler
- Recall Level: Level 3 Recall
- Recall Reason: The registration certificate number on the product's nameplate is incorrectly spelled as "国械注进20152553228" (National Medical Device Registration 20152553228). The correct registration certificate number should be "国械注进20162553228".
- Discovering Company: Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Medmax Electronic Medical Systems Trading (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medmax-electronic-medical-systems-trading-shanghai-co-ltd/41568b38-33b5-40e0-96db-249c51b42e4b