# 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/734b8a73-185e-468e-9bd5-d4da3666c7ab/
Source feed: China

> China NMPA product recall for Multifunctional incubator; infant incubator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published June 03, 2020. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has initiated a voluntary Class II re

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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 and infant incubators.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2020-06-03
- Product Name: Multifunctional incubator; infant incubator
- Recall Level: Level 2 Recall
- Recall Reason: It was discovered that some batches of Giraffe Incubator and Giraffe OmniBed products manufactured before 2012, equipped with Servo Oxygen servo oxygen systems, may have discrepancies between the actual output oxygen concentration and the monitored values.
- 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. has initiated a voluntary Class II recall for its multifunctional infant incubators, including the Giraffe Incubators and Giraffe OmniBeds. This action was reported to the National Medical Products Administration (NMPA) and publicized by the Shanghai Municipal Drug Administration. The core issue, identified in certain product batches manufactured before 2012, concerns a critical discrepancy in oxygen delivery: the actual oxygen concentration supplied by the incubator may deviate from the value displayed on the monitoring system. This malfunction presents a significant safety risk, as accurate oxygen levels are paramount for infant patients. The recall pertains to devices registered under CFDA (Imported) Certificate Nos. 2007 No. 3541963 and 2007 No. 3541819, underscoring adherence to Chinese medical device regulations. GE Healthcare is undertaking this measure to uphold patient safety, with comprehensive details regarding affected models, specifications, and batches provided 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/