China NMPA Product Recall - High-frequency electrosurgical unit

Shanghai Lishen Scientific Instruments Co., Ltd. initiated a voluntary Level II recall on December 23, 2019, for its high-frequency electrosurgical units. This action followed a national medical device supervision and spot check, which identified that the products did not conform to the safety requirements outlined in GB9706.4-2009, "Medical Electrical Equipment Part 2-2: Particular Requirements for Safety of High-Frequency Surgical Equipment," specifically sections 19.3.101 a) 3) and 19.3.101 b). Further analysis indicated that a potential malfunction of the TLP521-4 optocoupler within the device could lead to excessive bipolar application. The company conducted a risk analysis, determining that while the potential for harm was minimal, proactive measures were necessary. To date, no adverse events related to this issue have been reported. The recall is being managed under the oversight of the National Medical Products Administration (NMPA) through its local Shanghai authority. As a required action, Shanghai Lishen Scientific Instruments Co., Ltd. must prepare a comprehensive recall report detailing affected product models, specifications, and batch numbers. This voluntary recall emphasizes the company's commitment to product safety and compliance with national medical device standards.