# China NMPA Product Recall - Baby warming station

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/63695d11-5f94-4408-ab33-b06daa06b7cf/
Source feed: China

> China NMPA product recall for Baby warming station by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published May 19, 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: 2020-05-19
- 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 its infant warmers, as updated on May 19, 2020, following an initial report on January 21, 2020. This action was prompted by a critical safety issue: when operated in manual mode without a temperature probe, the device's heater continues to function at the user-set power. Crucially, this operation occurs without triggering an alarm or automatically reducing the output power, posing a potential risk. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, involves specific models, specifications, and batches of infant warmers (Registration Certificates CFDA (Imported) 2013 No. 3541372 and CFDA Import Registration No. 20163545180). GE Healthcare updated its initial recall report to reflect adjusted quantities of affected products imported and sold in China. The company is required to manage the recall process for these medical devices to address the identified safety concern.

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