# China NMPA Product Recall - Baby warming station

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/8c2584a2-6ef7-4125-a2df-e85bc5e71aa8/
Source feed: China

> China NMPA product recall for Baby warming station by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published January 21, 2020. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling baby warmers.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2020-01-21
- Product Name: Baby warming station
- Recall Level: Level 2 Recall
- Recall Reason: When the device is used in manual mode without a temperature probe, the heater can continue to operate at the user-set power without triggering an alarm or reducing the output power.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of certain infant warmers, as announced by the National Medical Products Administration (NMPA) on January 21, 2020. This action, also reported by the Shanghai Municipal Drug Administration (SFDA), addresses a significant safety concern. The primary issue identified is that when the infant warmer device is operated in manual mode without an attached temperature probe, the heating element continues to function at its user-set power level. Critically, this operation occurs without activating any alarm mechanisms or automatically reducing the heat output. This oversight presents a potential risk to patient safety, as excessive or uncontrolled heat could be delivered to an infant without proper notification or mitigation. The affected products are identified by Registration Certificate No.: CFDA (Imported) 2013 No. 3541372 and CFDA Import Registration No. 20163545180. The company’s proactive measure to voluntarily recall these devices aligns with medical device regulatory frameworks to ensure product safety and compliance. Detailed information regarding specific models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" accompanying the NMPA's announcement, guiding healthcare providers and users on the necessary steps to address the recalled units. This recall underscores the importance of continuous product monitoring and prompt corrective actions to safeguard public health.

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