China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall of specific electromagnetic wave therapy devices (Registration Certificate 20162260108). The recall, reported on January 2, 2020, and published by the National Medical Products Administration (NMPA) on January 22, 2020, addresses a critical safety concern. The affected devices, specifically model CQJ-25B with production batch number 1810259, manufactured on October 29, 2018 (50 units), failed to meet the regulatory requirement of maintaining balance when tilted at 10 degrees during normal operation. This instability poses a potential safety hazard during use. Operating under the oversight of the NMPA and the Sichuan Provincial Drug Administration, the company's corrective actions include distributing "Medical Device Recall Notices" to all sales points. These notices mandate that all medical institutions and operating units immediately cease selling the affected products and promptly return them to Chongqing Hualun Medical Device Co., Ltd. for necessary rework. This voluntary recall aims to effectively control the distribution of defective products and mitigate identified safety risks.