China NMPA Product Recall - High-potential therapy device

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.