China NMPA Product Recall - High-frequency surgical system and accessories

Soering GmbH, in conjunction with its agent Sieer (Beijing) Technology Development Co., Ltd., initiated a voluntary Class III recall of its high-frequency surgical systems and accessories, specifically one unit of the MBC600 model (serial number 92880709). The recall was reported to the National Medical Products Administration (NMPA) on July 31, 2017, and published on August 7, 2017. The primary reason for this action was non-compliance with external markings on the equipment or its components. Fortunately, the affected product had not yet been sold or shipped to end-users. As a corrective measure, Soering GmbH committed to performing the necessary label corrections before the product's shipment to ensure full compliance with regulatory standards.