China NMPA Product Recall - Specific electromagnetic wave therapy device

The National Medical Products Administration (NMPA) published an announcement on January 15, 2020, detailing a voluntary Class III recall initiated by Chongqing Runyang Medical Device Co., Ltd. The recall pertained to specific electromagnetic wave therapy devices, model TDP-CQ-28 (registration number 渝械注准20162260046), due to identified product non-compliance.The primary issue centered on the device's input power, which failed to meet established technical specifications. While the rated power was 230VA, with an allowable maximum of 253VA, actual measurements revealed an input power of 259.8VA. This measurement exceeded the standard by 6.8VA, representing a 1.2% deviation. The affected production batch, 28803021, encompassed 60 units distributed within China.In response to this violation of regulatory technical requirements, Chongqing Runyang Medical Device Co., Ltd. implemented prompt corrective actions. A recall notice was issued on October 16, 2019, leading to the retrieval of 16 non-compliant units from the implicated batch. By November 14, 2019, all recalled devices had been successfully replaced and returned to the distributors. The company formally submitted its recall event report on December 24, 2019, aligning with NMPA guidelines, thereby addressing the technical discrepancy and ensuring adherence to product standards.