# China NMPA Product Recall - Specific electromagnetic wave therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-aerospace-rocket-electronic-technology-co-ltd/82a5f82a-b2f5-467f-a112-8d7348009b8c/
Source feed: China

> China NMPA product recall for Specific electromagnetic wave therapy device by Chongqing Aerospace Rocket Electronic Technology Co., Ltd. published October 22, 2020. Recall level: Level 3 Recall. Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class III recall on

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Aerospace Rocket Electronic Technology Co., Ltd. voluntarily recalls
- Company Name: Chongqing Aerospace Rocket Electronic Technology Co., Ltd.
- Publication Date: 2020-10-22
- Product Name: Specific electromagnetic wave therapy device
- Recall Level: Level 3 Recall
- Recall Reason: The product does not comply with the requirement in section 42.5 of YY0306-2008 that "tools are required for removal".
- Discovering Company: Chongqing Aerospace Rocket Electronic Technology Co., Ltd.
- Manufacturing Company: Chongqing Aerospace Rocket Electronic Technology Co., Ltd.
- Summary: Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class III recall on October 22, 2020, concerning certain batches of its CO-10 electromagnetic wave treatment products. These products, specifically one batch comprising ten units manufactured in May 2018, were found to be non-compliant with section 42.5 of the YY0306-2008 standard. The primary issue identified was a design flaw where a critical component, which is mandated to require tools for removal, could be detached without the use of tools. This deviation from the established technical standard was formally reported to the National Medical Products Administration (NMPA), China's key regulatory body for medical devices. The company's required action involved executing a voluntary recall of all affected product batches. A detailed Medical Device Recall Event Report Form, dated January 18, 2019, documented the scope and reasons for this recall, reinforcing the company's commitment to address the product's non-conformance and ensure it meets safety and quality criteria for its intended use in adjunctive treatments.

Company: https://www.globalkeysolutions.net/companies/chongqing-aerospace-rocket-electronic-technology-co-ltd/c4674a85-e4d6-4cef-b604-2b7b75de760b/