China NMPA Product Recall - Infrared spectrum therapy device

Rongjie Health Technology Co., Ltd., formerly Anhui LG Health Technology Co., Ltd., initiated a voluntary Level III recall for its infrared spectrum therapy devices. This action stemmed from findings during the 2019 National Medical Device Sampling Inspection, which identified that the product's "Instructions for Use" did not meet the specified requirements. Specifically, the non-compliance was noted under inspection item "30250. Specific Electromagnetic Wave Therapy Device," as outlined in the 2019 National Medical Device Sampling Inspection Product Inspection Plan. The National Medical Products Administration (NMPA) publicized this recall on September 3, 2019, with the recall event reported on September 2, 2019. The affected devices were registered under certificate number

皖械注准20142260015. The required action by the company was a voluntary recall of these devices. A Level III recall typically signifies that the use of, or exposure to, the non-compliant product is unlikely to cause adverse health consequences. Detailed information concerning specific models, specifications, and batch numbers is provided in the associated Medical Device Recall Event Report Form.