China NMPA Product Recall - Electromagnetic field therapy device

Guangzhou Longzhijie Technology Co., Ltd. initiated a Class III voluntary recall of its LGT-2012 Electromagnetic Field Therapy Devices. This action, reported to the National Medical Products Administration (NMPA) on December 7, 2018, followed a random inspection in July 2018 by the Guangzhou Huangpu District Food and Drug Administration. The inspection revealed that a device from batch 2012023-2 failed to meet specific requirements of standard YY0505-2012. Key violations included non-compliance with radiation emission (item 36.201.1) and electrical fast transient burst (36.202.4) standards. In response, Guangzhou Longzhijie Technology Co., Ltd. implemented several corrective actions. The company issued product information notifications, contacted customers, and recalled all four units from the affected batch, offering replacements with their updated LGT-2000B model. Furthermore, they committed to inspecting the returned devices to ascertain the root cause of the non-conformance and undertake appropriate rectification. The LGT-2012 model has since been discontinued and replaced by the newly registered LGT-2000B, which is stated to resolve the identified issues, ensuring adherence to regulatory standards under the NMPA framework.