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

Source: https://www.globalkeysolutions.net/records/china_product_recall/soering-gmbh/4d9b9d92-beb3-4606-8285-277babeda974/
Source feed: China

> China NMPA product recall for High-frequency surgical system and accessories by Soering GmbH published August 14, 2017. Recall level: Level 3. Soering GmbH, in cooperation with its agent Soering (Beijing) Technology Development Co., Ltd., init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Soering GmbH initiates voluntary recall of high-frequency surgical systems and accessories
- Company Name: Soering GmbH
- Publication Date: 2017-08-14
- Product Name: High-frequency surgical system and accessories
- Recall Level: Level 3
- Recall Reason: External markings on equipment or equipment components do not comply with regulations.
- Discovering Company: Sisel (Beijing) Technology Development Co., Ltd.
- Manufacturing Company: Soering GmbH
- Summary: Soering GmbH, in cooperation with its agent Soering (Beijing) Technology Development Co., Ltd., initiated a voluntary Class III recall for its high-frequency surgical system and accessories, specifically model MBC600. This action, reported to the National Medical Products Administration (NMPA) on July 31, 2017, and publicly announced on August 14, 2017, was in response to a non-compliance issue. The primary concern was the inadequacy of external markings on the equipment or its components. The affected product, a high-frequency surgical system designed for cutting and coagulation of human tissue, involved a single unit from one production batch (serial number 92880709). A crucial aspect of this recall is that the identified unit had not yet been sold or distributed within the Chinese market. Operating under the NMPA's regulatory framework for medical devices, the required corrective action for this specific Class III recall is straightforward. Soering GmbH is mandated to perform a complete label correction on the identified product to ensure it complies with all necessary external marking standards. This rectification must be completed before the equipment is released for sale or shipment, thereby preventing any non-compliant units from reaching healthcare providers or patients and upholding product safety and regulatory adherence.

Company: https://www.globalkeysolutions.net/companies/soering-gmbh/bda88153-3753-4cae-b6d7-c675fd164b5b/