China NMPA Product Recall - High-frequency electrosurgical unit

On August 5, 2019, Shanghai Lishen Scientific Instruments Co., Ltd. initiated a Class III voluntary recall of its high-frequency electrosurgical units. This action followed a national medical device supervision and spot check, which identified that certain products failed to comply with sections 19.3.1013) and 19.3.101 b) of the GB9706.4-2009 standard, titled "Medical Electrical Equipment Part 2-2: Particular Requirements for Safety of High-Frequency Surgical Equipment." Investigations revealed a suspected malfunction in the TLP521-4 optocoupler within the units, resulting in excessive bipolar application. The recall was reported by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA). The company is taking corrective measures by removing the affected devices from circulation. Specific models, specifications, and batch details are provided in an attached Medical Device Recall Event Report Form. This recall emphasizes the company's commitment to product safety and compliance with national medical device regulations, ensuring patient safety and device efficacy.