# China NMPA Product Recall - Baby radiant warmer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/fca187f2-9b0d-43b4-b0a4-27b1753bb4c1/
Source feed: China

> China NMPA product recall for Baby radiant warmer by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published July 31, 2019. Recall level: Level 1 Recall. On July 31, 2019, the National Medical Products Administration (NMPA) and the Shanghai Food and Drug

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling infant radiant warmers.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-07-31
- Product Name: Baby radiant warmer
- Recall Level: Level 1 Recall
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On July 31, 2019, the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration announced an update to a Class I voluntary recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The recall pertains to several models of infant radiant warmers manufactured by the company. This action follows an initial recall reported on April 2, 2019. Key affected products include infant radiant warmers identified by specific registration certificate numbers, such as 国械注进20153540985, 国食药监械（进）字2010第3543186号, 国食药监械（进）字2010第3543187号, and 国械注进20153540683.

While the precise nature of the underlying issue prompting this Class I recall is not detailed in the public document, this classification signifies a high probability of serious adverse health consequences or even death associated with the product's use. The company is required to undertake comprehensive actions to address these potential safety concerns, involving the identification and management of affected batches. This recall underscores the regulatory oversight provided by the NMPA and Shanghai FDA in ensuring the safety of medical devices in the Chinese market. Further specifics regarding the affected product models, specifications, and batches are contained within the 'Medical Device Recall Event Report Form'.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/