China NMPA Product Recall - Infrared therapy device

Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class 3 recall for its Infrared Therapy Devices. The company reported this action on December 6, 2019, with the National Medical Products Administration (NMPA) publicly announcing it on January 15, 2020. This recall was prompted by identified product defects, specifically a critical non-conformance discovered during a provincial spot check in Sichuan. The main issue cited was the device's failure to meet the requirements of Clause 15b of GB9706.1-2007, a national standard for medical electrical equipment. This regulatory breach indicates a potential safety concern, necessitating immediate corrective measures. Under the regulatory framework of the NMPA and in compliance with national recall regulations, Chongqing Aerospace Rocket Electronic Technology Co., Ltd. promptly issued a notice to retrieve all 10 units of the affected Kefo CQ-32 model from the 2018/02 batch. The mandated action for these products is rectification, aiming to resolve the underlying defects and ensure adherence to safety standards. This proactive recall demonstrates the company's commitment to product safety and regulatory compliance.