China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall on January 2, 2020, regarding its specific Electromagnetic Wave Therapy Devices, identified by product number 1810259 and production batch number 1810259, manufactured on October 29, 2018. This action, published by the National Medical Products Administration (NMPA) on October 22, 2020, was prompted by a critical product defect. The primary issue identified was that the device failed to meet the essential safety requirement of maintaining stability, specifically "no imbalance when the device is tilted at 10° during normal use." This non-compliance posed a potential safety hazard, necessitating the recall to control defective products and mitigate risks to users. Under the regulatory oversight of the NMPA and the Chongqing Municipal Drug Administration, the company implemented clear corrective actions. All medical institutions and business units involved were strictly prohibited from further selling the affected devices. They were also mandated to promptly return the products to Chongqing Hualun Medical Device Co., Ltd. for necessary rework to rectify the identified stability flaw. This comprehensive recall aims to ensure product safety and compliance with established performance standards.