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

Source: https://www.globalkeysolutions.net/records/china_product_recall/soering-gmbh/d19fbbe3-0ddf-4dfe-bf57-204569027584/
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. Soering GmbH has initiated a voluntary Class III recall of its high-frequency surgical systems and r

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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: Soering GmbH has initiated a voluntary Class III recall of its high-frequency surgical systems and related accessories, as announced by the National Medical Products Administration (NMPA) on August 7, 2017. The recall, reported by Siser (Beijing) Technology Development Co., Ltd., stems from a non-compliance issue concerning external markings on the equipment and its components. This deficiency pertains to devices registered or noted under the number 20153251228. While specific inspection dates are not provided in this announcement, the action underscores a commitment to regulatory standards within the medical device sector.

Under the NMPA's regulatory framework, a Class III recall indicates that the use of, or exposure to, the affected product is unlikely to cause adverse health consequences. The required action for Soering GmbH is to remove the non-compliant high-frequency surgical systems and accessories from distribution. Detailed information regarding the specific models, specifications, and batch numbers of the affected products is contained within a 

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