# China NMPA Product Recall - Medical oxygen concentrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-aerospace-rocket-electronic-technology-co-ltd/15374567-99e9-41b9-beb0-ee778de58ce1/
Source feed: China

> China NMPA product recall for Medical oxygen concentrator by Chongqing Aerospace Rocket Electronic Technology Co., Ltd. published October 22, 2020. 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: 2020-10-22
- 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) Medical Oxygen Concentrators. This action, reported on December 11, 2019, and publicly announced by the National Medical Products Administration (NMPA) on October 22, 2020, stemmed from product defects identified during a random inspection in Chongqing. The inspection revealed that the medical devices failed to comply with critical technical requirements for product registration, specifically 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 YY0732-2009. These non-conformities indicate significant issues with the product's design or manufacturing standards. Operating under national medical device regulations, the company took responsibility by issuing a recall notice for the affected batch, comprising three units from the 2019/01 production run. The required action involves retrieving all units from this specific batch, followed by implementing improvements to address the identified deficiencies. This voluntary recall highlights the manufacturer's commitment to product safety and compliance within the regulatory framework overseen by the NMPA.

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