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

Source: https://www.globalkeysolutions.net/records/china_product_recall/soering-gmbh/b6ce9c8c-aa62-40e4-934d-b99c6a95fe67/
Source feed: China

> China NMPA product recall for High-frequency surgical system and accessories by Soering GmbH published August 07, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a Class III recall notice (Index No. JGXX

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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: 2017-08-07
- Product Name: High-frequency surgical system and accessories
- Recall Level: Level 3 Recall
- 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: The National Medical Products Administration (NMPA) issued a Class III recall notice (Index No. JGXX-2017-10762, published August 7, 2017) concerning high-frequency surgical systems and accessories manufactured by Soering GmbH. The recall was initiated by Sieer (Beijing) Technology Development Co., Ltd., the product's agent, with a report date of July 31, 2017. The primary issue prompting this recall is the non-compliance with external markings on the equipment or its components. Specifically, the affected product is identified as a High-Frequency Surgical System and Accessories, registered under certificate code 20153251228, model MBC600. One unit, identified by serial number 92880709, was impacted within China. Under the NMPA's regulatory framework for medical device recalls, the required corrective action involves performing label corrections on the product before it is shipped or sold. Notably, at the time of the recall, the affected unit had not yet been sold or distributed in China, preventing patient exposure or widespread distribution issues. This proactive measure ensures compliance with regulatory standards for product labeling before market release, mitigating potential risks associated with inaccurate or missing external product information.

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