China NMPA Product Recall - Medium and low frequency thermotherapy machine

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Dandong Dayang Electronic Instrument Factory, published on October 29, 2019. This recall concerns the company's low-frequency thermotherapy machine, registered under number 20152260094. The critical issue prompting this action is the non-standard marking of the fuse within these medical devices, a deviation from required manufacturing standards. Dandong Dayang Electronic Instrument Factory is undertaking this voluntary recall as a corrective measure. A Class III recall indicates that the product's use or exposure is unlikely to cause adverse health consequences. This initiative operates under the regulatory guidance of the NMPA, which maintains responsibility for upholding medical device safety and effectiveness in China. Comprehensive details, including specific models, specifications, and batch numbers of the affected products, are documented in the accompanying "Medical Device Recall Event Report Form" to facilitate proper identification and management of the recalled units by healthcare professionals and consumers.