China NMPA Product Recall - Specific electromagnetic wave therapy device

The National Medical Products Administration (NMPA) announced on April 12, 2021, a voluntary Class III recall initiated by Chongqing Runyang Medical Device Co., Ltd. for specific Electromagnetic Wave Therapy Devices (Model TDP-CQ-28). The recall stemmed from product non-compliance, specifically regarding the device's input power. Investigations revealed that the affected devices exceeded their stipulated technical requirements. The rated input power was 230VA, with an allowable range up to 253VA. However, actual measurements showed a reading of 259.8VA, surpassing the standard by 6.8VA. This constituted a 1.2% exceedance of the technical specification. In response, Chongqing Runyang Medical Device Co., Ltd. issued a recall notice on October 16, 2019, targeting batch number 28803021, which comprised 60 units sold in China. By November 14, 2019, 16 units from the affected batch were successfully recalled. All these recalled devices were subsequently replaced and returned to the respective distributor, as detailed in the Medical Device Recall Event Report Form submitted on December 24, 2019. This proactive measure ensured the resolution of the non-compliant products in accordance with NMPA's regulatory expectations.