China NMPA Product Recall - Intermediate frequency therapy device

Zhengzhou Yachen Biotechnology Co., Ltd. initiated a Level III voluntary recall of its Intermediate Frequency Therapy Devices (Model YC-8100, ID: 81501500A499) following a national supervision and inspection report (AH2019-GGC-00014). The inspection, reported on August 10, 2019, identified a critical non-compliance: the output lockout mechanism of the devices failed to meet the specified requirements of standard YY0607-2007, section 51.102. The company's internal investigation attributed this issue to a production process error affecting the recalled batch. This regulatory action, overseen by the National Medical Products Administration (NMPA), underscores the importance of product safety and adherence to established medical device standards. In response, Zhengzhou Yachen Biotechnology Co., Ltd. committed to implementing corrective actions. These include confirming and strengthening production procedures for future batches to prevent recurrence. Additionally, the company will provide comprehensive management system training to relevant personnel to ensure full compliance with regulatory requirements and quality control protocols. This recall aims to address the identified safety deficiency and uphold product integrity.