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

Source: https://www.globalkeysolutions.net/records/china_product_recall/soering-gmbh/8c032df1-ad3b-4e42-aced-956d337aca03/
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) announced a voluntary Class III recall initiated

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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) announced a voluntary Class III recall initiated by Soering GmbH for its high-frequency surgical systems and accessories, registered under certificate code 20153251228. This recall, reported on July 31, 2017, and published on August 7, 2017, was prompted by identified non-compliance issues related to external markings on the equipment or its components. Such markings are crucial for ensuring proper identification, safe usage, and adherence to regulatory standards for medical devices. Soering GmbH, with Sieer (Beijing) Technology Development Co., Ltd. acting as its agent in China, identified one affected batch, serial number 92880709, concerning the MBC600 model. Notably, at the time of the recall, zero units from this batch had been sold or shipped within China. Consequently, the required corrective action is proactive: label correction will be performed on the affected products before any future shipment occurs. This measure demonstrates the company's commitment to rectify the identified non-conformance prior to market release, ensuring all medical devices meet the NMPA's stringent regulatory framework regarding product labeling and safety information. The recall specifically targeted the single batch within China, preventing potential issues related to mislabeled products reaching healthcare professionals and patients.

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