China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall of its specific Electromagnetic Wave Therapy Devices (Product Number 1810259, Model/Specification CQJ-25B, Production Date October 29, 2018). This action, reported on January 2, 2020, and publicly announced by the National Medical Products Administration (NMPA) on April 12, 2021, addresses a significant safety concern. The primary issue identified is that the device fails to meet the crucial regulatory requirement of maintaining stability, specifically "no imbalance when tilted at 10° during normal use." This non-conformity poses a potential safety hazard during product operation. The recall affects 50 units sold in China. Under the guidance of the NMPA and local drug administration, Chongqing Hualun Medical Device Co., Ltd. is undertaking corrective actions. As part of this, all medical institutions and business units that have received these specific devices are prohibited from further sale. They are instructed to promptly return the affected products to the manufacturer for necessary rework to rectify the stability defect and ensure compliance with safety standards. This proactive measure aims to mitigate risks associated with the faulty device.