China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall for 50 units of its Specific Electromagnetic Wave Therapy Device (Model CQJ-25B, batch number 1812323), manufactured on December 28, 2018. This action, reported to the National Medical Products Administration (NMPA) on January 2, 2020, and publicly announced on January 22, 2020, addresses a critical product stability issue. The devices failed to meet the essential regulatory requirement of maintaining balance when tilted at 10 degrees during normal use, posing a potential safety risk to users. Under the NMPA's regulatory framework for medical device recalls, the company is undertaking comprehensive corrective actions. These include issuing formal Medical Device Recall Notices to all distribution channels and sales points. Furthermore, all medical institutions and operating units have been instructed to immediately cease sales of the affected product. Chongqing Hualun Medical Device Co., Ltd. is also coordinating the timely return of all recalled devices for rework to rectify the identified imbalance issue and ensure compliance with safety standards. This proactive measure aims to mitigate any potential hazards associated with the unstable devices.