China NMPA Product Recall - Electronystagmography; Auditory evoked potential system

Ertingmei Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its electronystagmography (Electronograph; Auditory Evoked Potential System) products, as announced by the National Medical Products Administration (NMPA) on September 3, 2019. This action was taken because the medical devices were found not to fully comply with current European Union (EU) basic electrical safety and performance regulatory standards. The primary concern identified was a potential risk of electric shock, which could affect both medical personnel and patients during use. The specific product involved is registered under certificate number 国械注进20152212285. This recall highlights the importance of adherence to international safety benchmarks for medical equipment distributed in the market. The company is responsible for addressing the non-compliance to mitigate potential hazards and ensure patient and user safety. Details regarding affected models, specifications, and batches are provided in an attached "Medical Device Recall Event Report Form," which guides the recall process. This proactive measure by Ertingmei Medical Devices underscores its commitment to product safety and regulatory compliance, ensuring that devices meet essential safety requirements to prevent adverse events.