# China NMPA Product Recall - Infant incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/likang-huayao-biotechnology-shanghai-co-ltd/9d22155d-1894-4208-8e2b-aec500c8c348/
Source feed: China

> China NMPA product recall for Infant incubator by Likang Huayao Biotechnology (Shanghai) Co., Ltd. published August 16, 2019. Recall level: Level 3 Recall. Likang Huayao Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its infan

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Likang Huayao Biotechnology (Shanghai) Co., Ltd. has voluntarily recalled its infant incubators.
- Company Name: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Publication Date: 2019-08-16
- Product Name: Infant incubator
- Recall Level: Level 3 Recall
- Recall Reason: The product in question failed to meet the requirements of section 49.2 of GB 11243-2008 during a national supervision and spot check. After analysis and testing, it was determined that the failure was likely due to an intermittent malfunction in the memory chip within the product.
- Discovering Company: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Manufacturing Company: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Summary: Likang Huayao Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its infant incubators on August 16, 2019, following a national supervision and spot check. The recall was prompted by the discovery that the incubators did not comply with section 49.2 of the GB 11243-2008 standard. Analysis and testing indicated that an intermittent malfunction of the product's memory chip was the likely cause of the non-compliance. While the company reported no related adverse event reports to date, the National Medical Products Administration (NMPA) document details the necessity of this action to address the identified product issue. The recall specifically targets infant incubators with Registration Certificate No.: 20153540700, with further details regarding specific models, specifications, and batches available in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with regulatory standards set by the NMPA.

Company: https://www.globalkeysolutions.net/companies/likang-huayao-biotechnology-shanghai-co-ltd/a9367c94-dcc5-49c7-b7fe-02c2c05c8569/