China NMPA Product Recall - UV curing machine

Bestar Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Level 3 recall of its UV Curing Machines (Model PM-LED04) in November 2018. This action, reported to the National Medical Products Administration (NMPA) of China, followed an internal inspection that identified two significant non-conformities with established product standards. The primary violations included the absence of the anti-electric shock level symbol on the product body, despite its presence on packaging and in the instruction manual, and the use of a red indicator light for the power charging status, which did not meet regulatory requirements. Although Bestar Medical Devices determined the probability of injury from these issues to be extremely low, and no adverse events had been reported, the company proactively addressed the non-compliance. Required actions involved immediately halting sales of the affected product, notifying customers about the recall of 6 units (3 sold in China), and implementing comprehensive corrective and preventive measures. This included identifying the root causes of the deviations, rectifying design flaws, reworking the remaining units, and submitting them to the Guangzhou Medical Device Quality Supervision and Inspection Center for re-inspection to ensure full adherence to medical device standards.