China NMPA Product Recall - Infrared therapy device

Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Level 3 recall of its Infrared Therapy Devices, specifically Model Kefo CQ-32 from the 2018/02 batch. This recall, formally reported on December 6, 2019, was prompted by the discovery of product defects. A routine spot check conducted in Sichuan Province found that these devices did not comply with the stringent requirements of Clause 15b of GB9706.1-2007, a critical national standard governing the safety and performance of medical electrical equipment.

Under the oversight of the National Medical Products Administration (NMPA) and local drug administrations, the company is responsible for ensuring its products meet these established regulatory benchmarks. The non-compliance led to a mandatory recall of 10 units of the affected batch, which had been distributed within Mainland China. As part of the required actions, Chongqing Aerospace Rocket Electronic Technology Co., Ltd. issued a comprehensive recall notice to retrieve all non-conforming products. The specified handling method for these recalled devices is rectification, indicating that the company plans to correct the identified deficiencies to bring the products into compliance. This incident underscores the importance of continuous adherence to national medical device standards to ensure patient safety and product efficacy.