# 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/8013d2f0-047f-4e3e-8c0c-a57cf6d389f7/
Source feed: China

> China NMPA product recall for Specific electromagnetic wave therapy device by Chongqing Aerospace Rocket Electronic Technology Co., Ltd. published April 12, 2021. Recall level: Level 3 Recall. Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class III medical d

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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: 2021-04-12
- 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 medical device recall, publicly announced on April 12, 2021, under the regulatory oversight of China's National Medical Products Administration (NMPA). The recall specifically involves the company's electromagnetic wave treatment device, Model CO-10. The primary issue identified was non-compliance with section 42.5 of the YY0306-2008 standard, which dictates that certain components must require tools for removal. Contrary to this requirement, a part of the affected devices could be detached without the use of tools, presenting a potential risk to product safety and operational integrity. The scope of the recall encompasses one batch of the Model CO-10 devices, consisting of 10 units produced in May 2018, with 9 units having been distributed and sold within mainland China. In response to this non-compliance, Chongqing Aerospace Rocket Electronic Technology Co., Ltd. implemented a voluntary recall for the entire identified batch. This corrective action was undertaken in accordance with national medical device regulations and the company's established recall management protocols, emphasizing the commitment to rectify product deficiencies and safeguard user safety. The NMPA's involvement underscores the stringent regulatory environment governing medical devices in China.

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