# China NMPA Product Recall - Multifunctional incubator, infant incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/1b1c4bb7-a5e4-41eb-9b7e-087cfed332a1/
Source feed: China

> China NMPA product recall for Multifunctional incubator, infant incubator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 04, 2019. Recall level: Level 1 Recall. On December 4, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a volu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling multi-functional incubators (including infant incubators).
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-12-04
- Product Name: Multifunctional incubator, infant incubator
- Recall Level: Level 1 Recall
- Recall Reason: If the operator does not pay attention and confirm, the equipment's bed board and opening may only appear to be closed but are not actually locked.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On December 4, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class I recall for specific models of its multi-functional incubators and infant incubators. This action, reported by the Shanghai Food and Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a significant safety issue. The main concern is that the equipment's bed board and opening may appear closed to operators but are not actually securely locked. This condition presents a potential safety risk, as it could lead to unexpected movement or detachment, potentially endangering patients, especially infants, who rely on these critical medical devices. The recall affects multiple registration certificate numbers for both multi-functional incubators (e.g., 2003-3540157, 20153544163) and infant incubators (e.g., 2007-3541819, 20183540070). A Class I recall designation indicates that there is a reasonable probability of serious adverse health consequences or death. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is implementing corrective actions to mitigate this risk, and detailed information on affected products is available in 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/