China NMPA Product Recall - UV curing machine

Bestar Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Class III recall of its UV curing machines (Model: PM-LED04, specific batches including 18D17758-18D17808) due to non-compliance with established medical device standards. This action was reported to the National Medical Products Administration (NMPA) on November 9, 2018, with a publication date of November 22, 2018. The primary issues identified were related to product labeling and design. Firstly, the anti-electric shock level symbol, though present on the packaging and in the instruction manual, was absent from the product body, failing to meet required placement standards. Secondly, the power charging status indicator light utilized a red color, which also did not conform to regulatory specifications. Bestar Medical Devices stated that the risk of injury from these issues was minimal, and no adverse events or complaints had been reported. Under the regulatory oversight associated with its Guangdong Medical Device Registration Certificate, Bestar took prompt corrective actions. These included immediately notifying customers, halting further sales of the affected product batches, and implementing a recall for rectification in accordance with non-conforming product control procedures. The company completed a thorough review, identified the root cause of the non-compliance, and performed necessary rework on remaining units. Post-rework, these units were submitted to the Guangzhou Medical Device Quality Supervision and Inspection Center for re-inspection of the corrected items, ensuring adherence to quality and safety standards.