China NMPA Product Recall - LED 光固化机

Foshan Yusen Medical Device Co., Ltd. initiated a Level III voluntary recall of its LED Curing Machines (Model DB686) following test failures indicating non-compliance with technical requirements YZB/粵0520-2011. The primary issue involved the charging base of certain units (Batch No.: 003017201707A, 2 units in China, 45 in Brazil) potentially using a red indicator light for charging status due to material mixing, conflicting with established standards. This action was reported to the National Medical Products Administration (NMPA) and the Guangdong Food and Drug Administration on September 29, 2018. Although no customer complaints or adverse events were reported, the company is implementing several corrective actions. These include immediate notification to distributors and clinics to cease sales and use of the affected products, recall and isolation of all non-conforming units, and a commitment to inspect all recalled products. Additionally, the company will implement corrective and preventative measures, including inspecting remaining inventory from a related batch (003017201706A) to ensure all products meet regulatory standards before distribution.