China NMPA Product Recall - Radiofrequency tissue coagulation system

B. Braun Medical (Shanghai) International Trading Co., Ltd., the agent for manufacturer Aesculap AG, initiated a Class II voluntary recall of specific Radiofrequency Tissue Coagulation Systems (Registration No.: CFDA (Imported) No. 20143252954). This action, publicly announced by the National Medical Products Administration (NMPA) on August 8, 2017, serves as a supplementary report to a previous recall from December 14, 2016, after additional affected products were identified. The recall was formally reported on June 19, 2017.The core issue is a defective electronic component from a supplier, which may lead to malfunctions in certain instruments, specifically the GN200 RF Transmitter Main Unit. While the system is designed to self-detect errors with visual and audible alarms, and no patient injuries have been reported, the defect poses a potential risk of prolonged surgical procedures. Eleven units, identifiable by specific serial numbers, were sold in China and are impacted.Under the regulatory framework governed by the NMPA and submissions to the Provincial Food and Drug Administration, B. Braun Medical (Shanghai) is required to verify and freeze all remaining affected inventory in China. Furthermore, the company must issue recall notices to all customers who received the products, obtain documented receipts, and ensure all recalled units are returned to the manufacturer for appropriate disposition. This voluntary recall highlights the company's adherence to regulatory standards for medical device safety.