# China NMPA Product Recall - Multifunctional Electro-ion Surgical Therapy Instrument

Source: https://www.keypedia.com/records/china_product_recall/nanning-kelun-new-technology-co-ltd/4c32a688-c284-4d4f-89d7-f11d556dd294
Source feed: China

> China NMPA product recall for Multifunctional Electro-ion Surgical Therapy Instrument by Nanning Kelun New Technology Co., Ltd. published January 23, 2019. Recall level: Level 3 Recall. Nanning Kelun New Technology Co., Ltd. initiated a voluntary Class III medical device recall, report

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanning Kelun New Technology Co., Ltd. voluntarily recalls its multifunctional electro-ion surgery treatment device.
- Company Name: Nanning Kelun New Technology Co., Ltd.
- Publication Date: 2019-01-23
- Product Name: Multifunctional Electro-ion Surgical Therapy Instrument
- Recall Level: Level 3 Recall
- Recall Reason: The label is incorrect; the label content is missing information regarding power connection conditions.
- Discovering Company: Nanning Kelun New Technology Co., Ltd.
- Manufacturing Company: Nanning Kelun New Technology Co., Ltd.
- Summary: Nanning Kelun New Technology Co., Ltd. initiated a voluntary Class III medical device recall, reported on January 14, 2019, and published by the National Medical Products Administration (NMPA) on January 23, 2019. The recall concerns their Multifunctional Electro-Ion Surgical Therapy Instrument, registered under certificate number Gui Shi Yao Jian Xie (Zhun) Zi 2013 No. 2260008. The primary issue identified was label printing errors, specifically the omission of crucial information regarding power connection conditions on the product's label. This recall affected a single batch, E161210, comprising 10 units of the GX-III model, all of which had been sold within China. The instrument is intended for various medical applications, including dermatology, surgery, and cosmetology. Under the NMPA's regulatory framework, a Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. To rectify the non-compliance, Nanning Kelun New Technology Co., Ltd. is required to reprint labels that accurately reflect the product's registration certificate and company standards. Additionally, the company must notify all users to ensure the replacement of the erroneous labels with the correct versions. This action aims to ensure product information accuracy and compliance with regulatory requirements.

Company: https://www.keypedia.com/companies/nanning-kelun-new-technology-co-ltd/957ba8b8-fb34-48f7-8b3e-6e3e937655f7