China NMPA Product Recall - Surgical energy system; Bipolar high-frequency ultrasound dual-output surgical system (USG-400 product)

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its surgical energy systems, specifically Bipolar High-Frequency Ultrasonic Dual-Output Surgical Systems, on September 12, 2019. This action followed an internal inspection where the company discovered a discrepancy in the software version of products manufactured after December 3, 2018, and subsequently marketed in China.The core issue identified was that these devices were equipped with software version 1.03, failing to meet the updated product technical requirements which specify software version 2. The revision for software version 2 primarily involved integrating intelligent tissue monitoring functionality. It is important to note that Olympus Trading (Shanghai) Co., Ltd. confirmed that this software version difference does not compromise product safety.Operating under the oversight of the National Medical Products Administration (NMPA) of China, the company is systematically withdrawing affected devices. Further specific details regarding the models, specifications, and batch numbers of the recalled products are comprehensively documented in the accompanying "Medical Device Recall Event Report Form," which stakeholders can access for complete information on the scope of the recall.