# China NMPA Product Recall - High-frequency electrosurgical unit

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-cam-nanyang-medical-instrument-co-ltd/21a24c73-619a-4fc0-adab-304bf9b2d625/
Source feed: China

> China NMPA product recall for High-frequency electrosurgical unit by Shanghai Cam Nanyang Medical Instrument Co., Ltd. published November 18, 2019. Recall level: Level 3 Recall. Shanghai Cam Nanyang Medical Devices Co., Ltd. initiated a proactive, Level III recall for its high-

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Cam Nanyang Medical Instrument Co., Ltd. voluntarily recalls high-frequency electrosurgical units.
- Company Name: Shanghai Cam Nanyang Medical Instrument Co., Ltd.
- Publication Date: 2019-11-18
- Product Name: High-frequency electrosurgical unit
- Recall Level: Level 3 Recall
- Recall Reason: The product failed to meet the requirements of item 19.3.101 c)2) in GB9706.4-2009 "Medical Electrical Equipment - Part 2-2: Safety of High-Frequency Surgical Equipment" during the national supervision and spot check.
- Discovering Company: Shanghai Cam Nanyang Medical Instrument Co., Ltd.
- Manufacturing Company: Shanghai Cam Nanyang Medical Instrument Co., Ltd.
- Summary: Shanghai Cam Nanyang Medical Devices Co., Ltd. initiated a proactive, Level III recall for its high-frequency electrosurgical units following findings from national supervision and spot checks. The recall, indexed by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (2019-263), was publicly announced on November 18, 2019. The core issue identified was that the product failed to meet specific safety requirements outlined in standard GB9706.4-2009, specifically section 19.3.101 c)2) for medical electrical equipment. Analysis by the company suggested that while the product passed initial type testing during registration, this particular safety item was not re-tested during factory inspections due to continuous product registration and unchanged manufacturing processes. Despite the assessed low potential risk, the company determined that effective control measures were necessary to mitigate any remaining risks. Consequently, a voluntary Level III recall was implemented. The company's post-market activities, including after-sales service and review of adverse event reports, indicate that all re-inspected inventory equipment has met the required standards. Detailed product information for the affected units, including models, specifications, and batch numbers, is available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/shanghai-cam-nanyang-medical-instrument-co-ltd/4965c522-7e3a-4b0a-a738-78d54c2b9dd0/