China NMPA Product Recall - Infrared therapy device

Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class 3 recall of its Kefo CQ-32 Infrared Therapy Devices. The recall, publicly announced on October 22, 2020, and reported by the company on December 6, 2019, stems from a spot check conducted in Sichuan Province. This check identified that the devices failed to meet the safety requirements outlined in Clause 15b of the GB9706.1-2007 national standard for medical electrical equipment, indicating a product defect. Operating under the regulatory oversight of the National Medical Products Administration (NMPA) and adhering to both national regulations and its internal recall management methods, Chongqing Aerospace Rocket Electronic Technology Co., Ltd. issued a notice for the recall of all products from the affected batch. The recall specifically targets one batch, comprising 10 units, identified by the batch number 2018/02, which were sold across mainland China. The primary corrective action involves the rectification of the identified issues, ensuring compliance with established safety standards. This proactive measure aims to address potential safety concerns related to the non-conforming infrared therapy devices.