China NMPA Product Recall - Intermediate frequency therapy device

Beijing Dongjie Huayi Medical Device Co., Ltd. initiated a Level III voluntary recall for its Intermediate Frequency Therapy Devices (batch 2018DH02), as formally reported on September 20, 2019, and published by the National Medical Products Administration (NMPA) on October 8, 2019. The recall stemmed from non-compliance with established regulatory and product standards. Specifically, the devices failed to meet requirements outlined in the YZB/京0954-2013 registered product standard concerning physiological effects, including symbols and warnings (item 6.1q). Additionally, the durability of the device's markings and the accessibility and clear marking of fuses (item 6.1n) did not conform to both the YZB/京0954-2013 standard and the GB9706.1-2007 national standard. In response, the company undertook corrective actions, notifying the three affected product users by phone and retrieving the devices. The non-compliant paper material used for product markings was replaced with more durable PVC material to ensure compliance. These corrections were also formally noted on the product's certificate of conformity, reinforcing the company's commitment to regulatory adherence and product safety standards within the Chinese market.