China NMPA Product Recall - Low-frequency therapy device

Guangzhou Jianmingxi Medical Instrument Co., Ltd. initiated a Class II voluntary recall of its Low-Frequency Therapy Devices (Registration No. 20182260277) on August 16, 2019, under the National Medical Products Administration (NMPA) framework in China. The recall addresses critical safety and quality issues identified in one batch of 20 units (models JMC-A2, identification D180151-D180170), of which 18 were sold in China. The primary violations include substandard fuse marking durability and an excessive energy output of over 10mA (r.m.s) and 10V (r.m.s) when the output amplitude controller is at its maximum. This non-compliance violates the technical requirements specified in YY 0607-2007, section 51.102, and the Guangdong Medical Device Registration Certificate 20182260277. No customer complaints or adverse events were reported. The company's required actions include immediately notifying all affected dealers and customers to cease sales and use of the devices. Recalled products must be isolated within the factory for inspection. Furthermore, Guangzhou Jianmingxi is mandated to implement corrective and preventative measures, including inspecting all recalled and remaining in-factory inventory for non-conformities.