China NMPA Product Recall - Radiofrequency therapy device

Medtech Medical Technology (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its radiofrequency therapy device. This action, reported on June 19, 2017, by the National Medical Products Administration (NMPA), stems from a significant discrepancy identified within the product documentation. The main issue concerns an inconsistency between the temperature and humidity requirements specified in the device's product instructions and those established in the official registered product standards. This divergence could potentially impact the device's performance or safety under certain environmental conditions. Although specific inspection dates are not provided, the company itself reported the issue leading to the recall. The regulatory framework under which this recall is managed is the National Medical Products Administration (NMPA) of China. As a required action, Medtech Medical Technology (Shanghai) Co., Ltd. is undertaking a Class III recall, which typically addresses situations where the probability of adverse health consequences is remote. Detailed information regarding the models, specifications, and batch numbers of the affected devices is available in the associated "Medical Device Recall Event Report Form" attachments, ensuring stakeholders can identify and address the implicated products appropriately.