# China NMPA Product Recall - Medical oxygen concentrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-aerospace-rocket-electronic-technology-co-ltd/412dbdc9-2256-4714-9898-500d18278d14/
Source feed: China

> China NMPA product recall for Medical oxygen concentrator by Chongqing Aerospace Rocket Electronic Technology Co., Ltd. published April 12, 2021. Recall level: Level 3. Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary recall of its YQ-53

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Aerospace Rocket Electronic Technology Co., Ltd. voluntarily recalls medical oxygen concentrators.
- Company Name: Chongqing Aerospace Rocket Electronic Technology Co., Ltd.
- Publication Date: 2021-04-12
- Product Name: Medical oxygen concentrator
- Recall Level: Level 3
- Recall Reason: Spot checks in Chongqing Municipality revealed that the products did not meet the technical requirements for product registration as specified in Clauses 1.6.1.a, 1.6.1.h, 1.6.1.n, 1.6.1.y, 2.6.3.f, and 2.6.3.g of GB9706.1-2007 and Clause 22.1.7.2 of YY0732-2009.
- 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 recall of its YQ-531 (Crane) model medical oxygen concentrators from the 2019/01 batch. This action, reported by the company on December 11, 2019, and publicly announced by the National Medical Products Administration (NMPA) on April 12, 2021, stemmed from product defects identified during a random inspection in Chongqing.The main issue was the failure of the medical devices to meet specific technical requirements outlined in their product registration, particularly Clauses 1.6.1.a, 1.6.1.h, 1.6.1.n, 1.6.1.y, 2.6.3.f, 2.6.3.g, and Clause 22.1.7.2 of the YY0732-2009 standard. These deficiencies indicate non-compliance with established quality and safety standards for medical devices.Operating under the regulatory oversight of the NMPA, the company classified this as a Level III recall, affecting three units sold in Mainland China. The required actions included issuing a formal notice to recall all affected products and implementing corrective improvements to address the identified non-conformities, aligning with national regulations and the company's internal recall management procedures.

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