China NMPA Product Recall - Low-frequency antiemetic device

Kunming Faros Technology Co., Ltd. has initiated a voluntary Class III recall for its low-frequency antiemetic device. This action follows a quality supervision and spot check conducted in Yunnan Province, which identified a non-compliance issue concerning the external marking of equipment parts. The specific violation indicated that the markings did not meet established standards. The recall, publicly announced on December 3, 2019, through the National Medical Products Administration (NMPA) and the Yunnan Provincial Drug Administration, pertains to devices registered under No. Yunnan Medical Device Registration 20172260031. A Class III recall signifies that the product's use is unlikely to cause adverse health consequences. The company's proactive measure demonstrates adherence to regulatory expectations by addressing identified deficiencies to ensure product quality and compliance. Detailed information regarding the affected product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This recall underscores the continuous oversight maintained by regulatory bodies like the NMPA to safeguard public health by ensuring medical devices meet specified quality and labeling requirements.