# China NMPA Product Recall - High-potential therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chuzhou-guokang-medical-instrument-co-ltd/d5bb7a4f-32de-4c41-bac5-ccb0c8f9fe9b/
Source feed: China

> China NMPA product recall for High-potential therapy device by Chuzhou Guokang Medical Instrument Co., Ltd. published October 25, 2018. Recall level: Level 3 Recall. Chuzhou Guokang Medical Instrument Co., Ltd. initiated a voluntary Class III recall of its high-pote

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chuzhou Guokang Medical Instrument Co., Ltd. voluntarily recalls high-potential therapy devices.
- Company Name: Chuzhou Guokang Medical Instrument Co., Ltd.
- Publication Date: 2018-10-25
- Product Name: High-potential therapy device
- Recall Level: Level 3 Recall
- Recall Reason: The low output voltage is caused by a faulty "fine-tuning capacitor".
- Discovering Company: Chuzhou Guokang Medical Instrument Co., Ltd.
- Manufacturing Company: Chuzhou Guokang Medical Instrument Co., Ltd.
- Summary: Chuzhou Guokang Medical Instrument Co., Ltd. initiated a voluntary Class III recall of its high-potential therapy device (Registration Certificate No. 20153260573) due to a critical quality defect. The recall, publicly announced on October 25, 2018, by the National Medical Products Administration (NMPA), addresses an issue with a defective "fine-tuning capacitor" within the device. This component malfunction results in the device producing an output voltage lower than its intended specifications, potentially affecting its therapeutic efficacy or patient safety. The regulatory oversight for this action falls under the National Medical Products Administration, which is responsible for ensuring the safety and effectiveness of medical devices. While specific inspection dates are not detailed, the company's proactive voluntary recall indicates its compliance with NMPA's medical device regulations. As a Class III recall, this action signifies that the product defect is unlikely to cause serious adverse health consequences but still warrants corrective measures to prevent potential harm. Chuzhou Guokang Medical Instrument Co., Ltd. is required to identify and retrieve all affected units from the market. Further detailed information regarding specific product models, specifications, and batch numbers subject to this recall is provided in the company’s "Medical Device Recall Event Report Form," which was attached to the NMPA's public notice.

Company: https://www.globalkeysolutions.net/companies/chuzhou-guokang-medical-instrument-co-ltd/b70bb9f0-f280-43e7-b278-2b7ccf8470d6/