# China NMPA Product Recall - High-frequency electrosurgical unit

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-cam-nanyang-medical-instrument-co-ltd/decdcfb9-af7b-4282-8600-c834242e16ad/
Source feed: China

> China NMPA product recall for High-frequency electrosurgical unit by Shanghai Cam Nanyang Medical Instrument Co., Ltd. published November 07, 2019. Recall level: Level 3 Recall. Shanghai Cam Nanyang Medical Devices Co., Ltd. initiated a voluntary Class III recall for its high-f

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Cam Nanyang Medical Instrument Co., Ltd. has voluntarily recalled its high-frequency electrosurgical unit.
- Company Name: Shanghai Cam Nanyang Medical Instrument Co., Ltd.
- Publication Date: 2019-11-07
- Product Name: High-frequency electrosurgical unit
- Recall Level: Level 3 Recall
- Recall Reason: The products in question failed to meet the requirements of item 19.3.101 c)2) in GB9706.4-2009 "Medical Electrical Equipment - Part 2-2: Particular Requirements for Safety of High-Frequency Surgical Equipment" during national supervision and spot checks.
- 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 voluntary Class III recall for its high-frequency electrosurgical units, as announced on November 7, 2019, by the National Medical Products Administration (NMPA). The recall stems from national supervision and spot checks which revealed that the products failed to meet specific requirements, item 19.3.101 c)2), of the GB9706.4-2009 "Medical Electrical Equipment Part 2-2: Safety Requirements for High-Frequency Surgical Equipment" standard.

Although the company previously passed type testing for this item during product registration and stated that manufacturing processes and materials had not changed, the particular requirement was not re-tested during subsequent factory inspections. Through an internal risk analysis, Shanghai Cam Nanyang Medical Devices Co., Ltd. determined that despite the potential risk being assessed as very small, proactive measures were necessary to mitigate it further.

As a required action, the company is voluntarily recalling affected high-frequency electrosurgical units (Registration Certificate No.: 20163252272). As part of the recall process, the company has conducted after-sales follow-ups, reporting no adverse event reports related to the issue, and re-inspected inventory equipment, which showed qualified results. Detailed information on specific models, specifications, and batches is available in the "Medical Device Recall Event Report Form."

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