China NMPA Product Recall - Medium and low frequency electrotherapy machine

Dandong Haihua Applied Technology Development Co., Ltd. initiated a voluntary recall of its low-frequency electrotherapy machines, as reported by the National Medical Products Administration (NMPA) on October 29, 2019. The recall, classified as level three, was prompted by a critical product labeling deficiency. Specifically, the model and nominal value of the externally accessible fuse on the electrotherapy machines were not clearly marked on the product surface. This lack of clear labeling poses a potential safety concern, as users or service personnel might not be able to correctly identify or replace the fuse, which is a vital safety component. The affected products carry the registration number Liaoning Medical Device Registration 20152260108. This action, overseen by the NMPA through the Liaoning Provincial Drug Administration, underscores the importance of stringent product labeling standards within the medical device industry in China. Dandong Haihua Applied Technology Development Co., Ltd. is responsible for implementing this recall to address the identified non-conformance and ensure product safety. Further details regarding specific models, specifications, and batches are contained within the "Medical Device Recall Event Report Form" attachment, guiding the company's corrective measures. This proactive step aims to mitigate any potential risks associated with the mislabeled fuses and uphold patient safety.